| Class 2 Device Recall zimmer Trabecular | |
Date Initiated by Firm | August 02, 2006 |
Date Posted | August 31, 2006 |
Recall Status1 |
Terminated 3 on May 04, 2007 |
Recall Number | Z-1472-06 |
Recall Event ID |
35943 |
510(K)Number | K051491 |
Product Classification |
hip prosthesis - Product Code LPH
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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). |
Code Information |
Lots 60454312 and 60461052. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
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For Additional Information Contact | Connie 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 |
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. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LPH
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