Recalls / —
—#38573
Product
Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
- FDA product code
- JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K953337
- Affected lot / code info
- Lot 60252787.
Why it was recalled
May be mislabeled as to dimensions; may be 12/14 taper, 28mm dia., neck length +3.5mm.
Root cause (FDA determination)
Other
Action the firm took
Consignees were notified via certified letter dated 4/6/05.
Recalling firm
- Firm
- Zimmer Inc.
- Address
- 345 E Main St, Warsaw, Indiana 46580-2746
Distribution
- Distribution pattern
- Nationwide and Canada.
Timeline
- Recall initiated
- 2005-04-15
- Posted by FDA
- 2005-08-03
- Terminated
- 2005-08-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #38573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.