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Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp. Recalls

All product recalls associated with Stryker Howmedica Osteonics Corp..

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Recall Summary

Total Recalls

180

Past Year

Class I (Serious)

Most Recent

Dec 2014

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 81–100 of 180 recalls

Stryker Howmedica Osteonics Corp.: Omnifit HFX Hip Stem These devices are modular components...

Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

FDANov 13, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Secur-Fit ARC/HA Collar Stem These devices are modular c...

Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.

FDANov 13, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Ci...

The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.

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Page 5 of 9Next

FDA

Aug 20, 2008

Nationwide

• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Osteosynthesis Reduction Spoon; 1 single unit to ...

Stryker has become aware of the potential for breakage of the Reduction Spoon designed prior to 2003.

FDAAug 14, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio Series 7000 Tibial Impactor/Extractor, Catalog nu...

Stryker Orthopaedics became aware that there is a potential inability to release the Scorpio Series 7000 Tibial Impactor/Extractor from a tibial baseplate during use.

FDAJul 2, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stem Trial, Triathlon Revision Instruments; Non-Sterile; ...

Triathlon TS Stems Trails may crack, potentially causing fragments of the plastic handle to fragment and break off completely.

FDAMay 14, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Universal Notch Preparation Guide, Size #3; Non Sterile; ...

Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.

FDAMar 18, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: X-Celerate Universal Block Pegless Size #3, Non Sterile;

Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.

FDAMar 18, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon TS Femoral Trial; Size 1 Left Non-Sterile Catal...

Laceration Risk

Sharp edges will cause a glove to tear and cut someone. Sharp edges on the slots machines in select lots of the Triathlon TS Femoral Trials, sizes 1-8, have been discovered.

FDAMar 5, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Gammas Set Screwdriver Instrument Set, Basic Stryker Trau...

Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification.

FDAFeb 22, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Gamma 3 System Set Screwdriver, Flexible Shaft; 4mm, Thi...

Stryker Trauma has become aware that five lots of the Gamma3 Set Screwdriver have hexagon tips that were not hardened to specification. If the screwdriver tip were to deform intra-operatively, the correct positioning of the set screw would not be possible, which could lead to lateral or medial migration of the lag-screw.

FDAFeb 22, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics, Locking Screw, T7, Catalog Number:...

Screws do not have locking threads

FDAJan 28, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-...

Rejuvenate Broach system was designed in a manner that may result in the potential for a medical calcar fracture.

FDAJan 25, 2008Nationwide• Stryker Howmedica Osteonics Corp.