Z-1470-06
Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150...
Zimmer GmbH / initiated 2006-08-02 / Terminated
Zimmer Inc. began a recall of Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile... 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-1470-06
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Zimmer GmbH
- Product
- Zimmer VERSYS Hip System Femoral Stem, press-fit, enhanced taper, 12/14 neck taper, collarless, size 17, 150 mm stem length, tivanium TI-6AL-4V alloy, sterile; Cat. no. 7861-17-04 (00786101704).
- Product code
- LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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 60454205, 60454206 and 60465024.
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