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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer ZMR

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 Class 2 Device Recall Zimmer ZMRsee related information
Date Initiated by FirmAugust 02, 2006
Date PostedAugust 31, 2006
Recall Status1 Terminated 3 on May 04, 2007
Recall NumberZ-1476-06
Recall Event ID 35943
510(K)NumberK994286 
Product Classification hip prosthesis - Product Code LPH
ProductZimmer ZMR Hip System femoral body, revision, nitrided, porous, 12/14 neck taper, extended, 46 mm neck offset, spout body, size D, 35 mm build-up, tivanium TI-6AL-4V alloy, sterile; REF. 9990-20-46 (Cat. no. 00999002046).
Code Information Lot 60465192.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information ContactConnie Morgan
800-846-4637
Manufacturer Reason
for Recall
Lack of assurance of proper metal fatigue strength due to a metal grain structure anomaly.
FDA Determined
Cause 2
Other
ActionConsignees 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 Commerce181 of all devices
DistributionWorldwide, including USA, Australia, China, Denmark, Japan, Jordan, Latin Ameria, Russia, Singapore and Switzerland.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LPH
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