Recalls / —
—#34627
Product
Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
- FDA product code
- KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K013385
- Affected lot / code info
- lot 60004557; Exp. December 2008.
Why it was recalled
The polyethylene tibial bushing was omitted from the taper of the tibial plates.
Root cause (FDA determination)
Other
Action the firm took
Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
Recalling firm
- Firm
- Zimmer Inc.
- Address
- 345 E Main St, Warsaw, Indiana 46580-2746
Distribution
- Distribution pattern
- Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
Timeline
- Recall initiated
- 2004-08-03
- Posted by FDA
- 2004-09-14
- Terminated
- 2004-09-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34627. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.