OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
FDA Recall Z-2055-2008 · Posted 2008-09-16
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWT
Date Initiated2005-03-09
Date Terminated2008-09-24
Product QuantitySell sheets: 1919, Cutting Edge Advantage Brochure: 810
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.
Firm Action
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
Distribution Pattern
Worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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