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  • Class 2 Device Recall Bearing Sleeve, 19CM Straight

    1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.

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  • Medical Device Standards and Implant Standards

    ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipments. These apparatuses are used in surgical procedures that involve the placement of such devices to specified parts and structures of the body (both humans and ...

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  • MAUDE Adverse Event Report: BIOMET

    Upon removal, it was noted that the taper adapter and the bearing were damaged. Additional information received indicates that the central screw was not fully seated. This issue was noted during the revision procedure on (b)(6) 2013 and the central screw was also removed and replaced.

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  • Smith+Nephew Medical Devices and Advanced

    Smith+Nephew is a leading portfolio medical technology company. We design and make technology that takes the limits off living. About us. Orthopaedics Sports medicine and ear, nose & throat Advanced wound care. All products

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  • Zimmer Biomet CoCr and Ceramic Femoral Heads

    2020-1-10 · to include a 12/14 taper or Type I taper. Sleeved options include taper adaptors compatible with 12/14, Type 1 and 6° femoral stem tapers. See the applicable Ordering Information document for detailed product descriptions. Non-sleeved ceramic femoral heads should only be implanted on pristine/non-damaged stems. In revision

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  • Mounting and Dismounting of Rolling Bearings

    2019-5-25 · port for the bearing, mounting and dismounting equipment, measur - ing devices, heating facilities, type and quantity of lubricant. 2.2 The „Right“ Bearing Prior to mounting, the bearing serviceman must make sure that the bearing number stamped on the package agrees with the designa - tion given on the drawing and in the parts list.

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  • Bearing designs - Tapered roller bearing units

    2020-12-13 · Tapered roller bearing units (TBUs) consist of two inner rings, one common outer ring, two tapered roller and polymer cage assemblies, a central spacer, grease fill and two sealing systems. Further components like lateral spacers, backing rings and end caps with their locking device can be added to the assembly as well as components based on

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  • Zimmer NexGen CR-Flex and LPS-Flex Knees

    2020-1-12 · removal of the IM rod, the alignment guide and the resection guide at the same time. If necessary, the round end of the Slaphammer Extractor can be used in conjunction with the central hole in the T-Handle to remove the IM rod. Cut the distal femur through the cutting slot in the cutting head, using a 1.27mm (0.050 in.) oscillating saw blade

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  • Timken Bearing Damage Analysis with Lubrication

    2020-7-22 · components adjacent to the bearing, including locknuts, adapters, seals and seal wear rings. 8. Mark and record the mounted position of the bearings and components prior to removal. 9. Measure and verify shaft and housing size, roundness and taper using certified gauges. 10. Following removal, but before cleaning, record

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  • Material loss at the taper junction of retrieved large ...

    2013-8-5 · The median volume (0.29 mm 3) was significantly less than that lost from the female taper and the head and acetabular bearing surfaces (all p < 0.001). Comparison of the taper and bearing surface data is shown in Figure 3. Material loss from the female taper was greater than that from the combined bearing surfaces in only 23% of the cases.

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  • BD Safe Clip Needle Removal Device at HealthyKin.com

    2020-6-24 · BD Safe Clip Needle Removal Device from HealthyKin.com removes insulin syringe needles and pen needles safely and easily. This portable device holds up to 1,500 clipped needles - approximately a 2-year supply. The BD Safe-Clip Device makes the syringe unusable by …

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  • Comparison and appraisal of techniques for the ...

    To improve modular implant performance, medical device manufacturers have adopted numerous design philosophies, each presenting a unique set of challenges for the measurement of material loss. This review summarises the approaches used in previous studies to overcome these challenges and identifies future work required in this area.

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  • ASTM International - Medical Devices and Services -

    Medical Devices and Services. E11-20 - Standard Specification for Woven Wire Test Sieve Cloth and Test Sieves. E161-17 - Standard Specification for Electroformed Material and Test Sieves. E323-11(2016) - Standard Specification for Perforated-Plate Sieves for Testing Purposes E454-12(2016) - Standard Specification for Industrial Perforated Plate and Screens (Square Opening Series)

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  • Modular to Monoblock: Difficulties of Detaching the

    2020-12-31 · Stem revisions included one case in which the taper adapter was successfully removed with an extraction tool, but the taper was severely damaged, requiring a stem revision . The median preoperative chromium and cobalt ion level of the cases with difficult head removal (ion levels available in 80% [16 of 20] of cases) was 8.0 μg/L (range, 0.8 ...

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  • Five Hundred Fifty-five Retrieved Metal-on-metal Hip ...

    Background: In 2010, a widely used metal-on-metal hip implant design was voluntarily recalled by the manufacturer because of higher than anticipated failure rates at 5 years. Although there was a large published range of revision rates, numerous studies had reported a higher risk of revision for excessive wear and associated adverse tissue reactions when compared with other metal-on-metal ...

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  • Bearing mounting | Basic Bearing Knowledge | Koyo ...

    Table 15-1 Press fit of bearings with cylindrical bores. As shown in the Fig., a bearing should be mounted slowly with care, by using a fixture to apply force evenly to the bearing. When mounting the inner ring, apply pressure to the inner ring only. Similarly, in mounting the outer ring, press only the outer ring.

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  • Bearing preload: What is it and why is it important ...

    2019-6-11 · If the bearing has a tapered bore the bearing is driven onto the taper, resulting in an interference fit. This causes the inner ring to expand and exert a radial force on the rollers to create the proper preload. Preload methods. The two main methods of bearing preload are rigid and spring.

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  • NTN – Industrial Bearing

    List of bearings and other products. NTN provides a wide variety of products to suit the needs of customers, ranging from simple ball bearings through to bearing units, automotive products, precision machinery, condition monitoring systems, composite material …

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  • Bearing killers: Preventing the top causes of bearing ...

    2014-2-10 · Feb 10, 2014. The top bearing “killers,” or causes of damage and premature end of bearing life, are inadequate lubrication, contamination, overload, and improper handling and installation ...

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  • Material loss at the taper junction of retrieved large ...

    The median volume (0.29 mm 3) was significantly less than that lost from the female taper and the head and acetabular bearing surfaces (all p < 0.001). Comparison of the taper and bearing surface data is shown in Figure 3. Material loss from the female taper was greater than that from the combined bearing surfaces in only 23% of the cases.

    Get Price
  • Influence of Different Damage Patterns of the Stem

    2020-5-14 · Background . Modularity finds frequent application in total hip replacement, allowing a preferable individual configuration and a simplified revision by retaining the femoral stem and replacing the prosthetic head. However, micromotions within the interface between the head and the stem taper can arise, resulting in the release of wear debris and corrosion products.

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  • Ascension PyroCarbon Lunate Implant - Smith+Nephew

    2020-10-27 · Polished bearing and taper surfaces must not come in contact with hard or abrasive surfaces . Contact between ... Medical device manufacturers and users are required by law and regulation to report serious injuries and death . 3 7. SURGICAL PROCEDURE ... removal techniques and the instrumentation . Please contact

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  • FineHeart Breaks New Ground With Successful

    2021-5-4 · FineHeart S.A a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients ...

    Get Price
  • ASTM International - Medical Devices and Services -

    Medical Devices and Services. E11-20 - Standard Specification for Woven Wire Test Sieve Cloth and Test Sieves. E161-17 - Standard Specification for Electroformed Material and Test Sieves. E323-11(2016) - Standard Specification for Perforated-Plate Sieves for Testing Purposes E454-12(2016) - Standard Specification for Industrial Perforated Plate and Screens (Square Opening Series)

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  • Investigation of Taper Failure in a Contemporary Metal on ...

    2020-8-8 · taper surface appeared to be the most important variable associated with taper wear (p<0.001). The best fitting regression model including duration in vivo, head offset, Rpk value, stem shaft angle and bearing surface wear rate explained approximately 44% of the variation in taper wear rates.

    Get Price
  • Foot & Ankle | Wright Medical Group

    Wright leads the way with an impressive history of ground-breaking products for the foot and ankle industry. In 2014, Wright transformed itself from a

    Get Price
  • Bearing mounting | Basic Bearing Knowledge | Koyo ...

    Table 15-1 Press fit of bearings with cylindrical bores. As shown in the Fig., a bearing should be mounted slowly with care, by using a fixture to apply force evenly to the bearing. When mounting the inner ring, apply pressure to the inner ring only. Similarly, in mounting the outer ring, press only the outer ring.

    Get Price
  • Bearing killers: Preventing the top causes of bearing ...

    2014-2-10 · The top bearing “killers,” or causes of damage and premature end of bearing life, are inadequate lubrication, contamination, overload, and improper handling and installation.

    Get Price
  • Stryker | Accolade Femoral Stem | Which Medical Device

    2012-4-22 · From Which Medical Device . The Accolade femoral stem from Stryker is an uncemented, proximally coated, collarless femoral component manufactured from Stryker’s proprietary beta titanium alloy, TMZF. TMZF has a modulus of elasticity closer to that of bone than Ti-6Al-4V alloy.

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  • Mechanical Maintenance Training Course

    2021-6-11 · MECHANICAL MAINTENANCE TRAINING COURSE COURSE 700: 5 DAYS: Max 4 Candidates. This course provides personnel with the necessary skills to perform mechanical maintenance, including the removal and replacement of equipment (pumps, gearboxes, motors and power transmission systems) and identification and rectification of bearing faults within these systems.

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  • Ascension PyroCarbon Lunate Implant - Smith+Nephew

    2020-10-27 · Polished bearing and taper surfaces must not come in contact with hard or abrasive surfaces . Contact between ... Medical device manufacturers and users are required by law and regulation to report serious injuries and death . 3 7. SURGICAL PROCEDURE ... removal techniques and the instrumentation . Please contact

    Get Price
  • FineHeart Breaks New Ground With Successful

    2021-5-4 · FineHeart S.A a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients ...

    Get Price
  • Foot & Ankle | Wright Medical Group

    Wright leads the way with an impressive history of ground-breaking products for the foot and ankle industry. In 2014, Wright transformed itself from a

    Get Price
  • Fracture of the cone of a morse taper junction in revision ...

    2018-4-4 · left hip breakage of the cone of the morse taper junction was visible (Figure 6). Removal of the well-fixed stem was performed via a distal fenestration. After fixation with cerclage wires a bended MRP Titan revision stem (Diameter: 19 mm, Length: 200mm with long neck and extension sleeve) was implanted using a 32 mm ceramic head (Figure 7).

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  • New Universe Bearing Co., Ltd - Deep groove ball

    Medical CE advanced big power laser tattoo removal q switched nd yag laser; best selling products in america laser equipment co2 fractional for scar removal; High quality Ip67 junction box electric box over 20 years experience; High quality heavy duty metal tool boxes waterproof hinged metal box with die casting aluminum enclosure

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  • Stryker | Accolade Femoral Stem | Which Medical Device

    2012-4-22 · From Which Medical Device . The Accolade femoral stem from Stryker is an uncemented, proximally coated, collarless femoral component manufactured from Stryker’s proprietary beta titanium alloy, TMZF. TMZF has a modulus of elasticity closer to that of bone than Ti-6Al-4V alloy.

    Get Price
  • Knee Replacement Implant Types, Revision Surgery &

    Heart attack, stroke or lung complications (rare) Revision surgery rates for knee replacements are quickly rising. In 2010, more than 55,000 revision surgeries were performed in the U.S., with 48 percent of the revisions in patients under 65. Total costs for each surgery averaged to be more than 49,000.

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  • Materials Handling and Storage

    2021-2-4 · 3 Using the following personal protective equipment prevents needless injuries when manually moving materials: Hand and forearm protection, such as gloves, for loads with sharp or rough edges. Eye protection. Steel-toed safety shoes or boots. Metal, fiber, or plastic metatarsal guards to protect the instep area from impact or compression.

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  • Wuxi GuangYue Bearing Co., Ltd - bearing from China

    Wuxi GuangYue Bearing Co., Ltd. ContactVicky Lee; Phone86-510-82619610; AddressNO 638, Xing Yuan North Road, Wuxi, Jiangsu, China Wuxi,Jiangsu

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  • Honing, Lapping, and Super-finishing Machines

    Typically, honing stock removal consists of only a few thousandths of an inch, but larger material removal of up to 0.250 in. is possible with coarse grit rough honing processes. When higher material removal rates are required, alternative grinding or machining methods can be more efficient to use before honing to reduce honing time and costs.

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  • Foot & Ankle | Wright Medical Group

    Wright leads the way with an impressive history of ground-breaking products for the foot and ankle industry. In 2014, Wright transformed itself from a

    Get Price
  • Ascension PyroCarbon Lunate Implant - Smith+Nephew

    2020-10-27 · Polished bearing and taper surfaces must not come in contact with hard or abrasive surfaces . Contact between ... Medical device manufacturers and users are required by law and regulation to report serious injuries and death . 3 7. SURGICAL PROCEDURE ... removal techniques and the instrumentation . Please contact

    Get Price
  • exeter protocol 10 - Stryker MedEd

    2016-2-25 · the morse taper. Post-operative management The post operative management and programme of rehabilitation will depend on the acetabular side of the revision procedure. With regard to the femoral stem, full weight bearing can commence as soon as patient comfort will allow. Considerations: 1. The technique is only appropriate for use in infected

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  • A technique for anchor plug salvage in the setting of a ...

    2019-8-27 · The fracture was identified, and confirmed to be at the male portion of the taper adapter . We attempted to disengage the taper adapter from the spindle, but deformed two pitch-fork removal devices in the process and failed to remove it using a bone tamp. It became clear at this point that the two implants were cold-welded together.

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  • Starrett Precision Measuring Tools and Saw Blades

    Starrett: Micrometers, Gages, Machinist Tools, Force Measurement, Precision Granite, Video Measurement, Optical Comparators, Band Saw, Jobsite Tools..

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  • Investigation of Taper Failure in a Contemporary Metal on ...

    2020-8-8 · taper surface appeared to be the most important variable associated with taper wear (p<0.001). The best fitting regression model including duration in vivo, head offset, Rpk value, stem shaft angle and bearing surface wear rate explained approximately 44% of the variation in taper wear rates.

    Get Price
  • Fracture of the cone of a morse taper junction in revision ...

    2018-4-4 · left hip breakage of the cone of the morse taper junction was visible (Figure 6). Removal of the well-fixed stem was performed via a distal fenestration. After fixation with cerclage wires a bended MRP Titan revision stem (Diameter: 19 mm, Length: 200mm with long neck and extension sleeve) was implanted using a 32 mm ceramic head (Figure 7).

    Get Price
  • Stryker | Accolade Femoral Stem | Which Medical Device

    2012-4-22 · From Which Medical Device . The Accolade femoral stem from Stryker is an uncemented, proximally coated, collarless femoral component manufactured from Stryker’s proprietary beta titanium alloy, TMZF. TMZF has a modulus of elasticity closer to that of bone than Ti-6Al-4V alloy.

    Get Price
  • FineHeart Breaks New Ground With Successful

    2021-5-4 · FineHeart S.A a preclinical medical device company that has developed the ICOMS FLOWMAKER®, an Implantable Cardiac Output Management System designed to address the unmet need of patients ...

    Get Price
  • greenlight.guru’s QMS helps medical device

    2015-2-10 · Indianapolis, Indiana – greenlight.guru announced the public release of its cloud-based quality management software exclusively for the medical device community. greenlight.guru allows medical device manufactures to bring new products to market faster while reducing risk by providing them an integrated quality system that is easy to use and designed for regulatory compliance.

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