Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1472-06

Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper...

Zimmer GmbH / initiated 2006-08-02 / Terminated

Zimmer Inc. began a recall of Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm... 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-1472-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Zimmer GmbH
Product
Zimmer Trabecular metal primary hip prosthesis femoral stem, press-fit, collarless, 12/14 neck taper - standard body -extended neck offset, size 15, 160 mm stem length, sterile, tivanium TI-6AL-4V alloy/tantalum, sterile; Cat. no. 00-7864-015-20 (00786401520).
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 60454312 and 60461052.