Z-1474-06
Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+, tivanium TI-6AL-4V...
Zimmer GmbH / initiated 2006-08-02 / Terminated
Zimmer Inc. began a recall of Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile; REF. (Cat. no... on . The reason FDA records is "Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-1474-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Zimmer MAYO Conservative hip prosthesis femoral stem, porous, 12/14 neck taper, large+, tivanium TI-6AL-4V alloy, sterile; REF. 8026-13-05 (Cat. no. 00802601305).
- Product code
- LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Reason for recall
- Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
- FDA root cause
- Other
- Action
- Consignees were notified via letter dated 8/2/06 to cease use of and to return the products. Zimmer distributors were to examine stock and return product on hand.
- Quantity in commerce
- 181 of all devices
- Distribution
- Worldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
- Product codes and lots
- Lots 60450985 and 60450986.
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