Recalls / —
—#70858
Product
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 product code
- HWT — Template
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Literature number: LHFX-SS rev 1; Cutting Edge Advantage Brochure w/inserts, Literature Number: LCEA-B
Why it was recalled
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.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2002
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2005-03-09
- Posted by FDA
- 2008-09-16
- Terminated
- 2008-09-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #70858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.