OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical
FDA device recall Z-2055-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.
- Action taken
- Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005. For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HWT
- Quantity affected
- Sell sheets: 1919, Cutting Edge Advantage Brochure: 810
- Distribution
- Worldwide
- Date initiated
- 2005-03-09
- Date posted
- 2008-09-16
- Date terminated
- 2008-09-24
- Location
- Mahwah, NJ
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