Recalls / —
—#65271
Product
Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsaw, IN, 46581-0708.
- FDA product code
- KXA — Prosthesis, Hip, Femoral, Resurfacing
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K070292
- Affected lot / code info
- Lot 2376766.
Why it was recalled
Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
Root cause (FDA determination)
Packaging process control
Action the firm took
Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall.
Recalling firm
- Firm
- Zimmer Inc.
- Address
- 345 E. Main St., Warsaw, Indiana 46580-2304
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2007-09-26
- Posted by FDA
- 2007-11-29
- Terminated
- 2008-06-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #65271. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.