Date Initiated by Firm |
September 26, 2007 |
Date Posted |
November 29, 2007 |
Recall Status1 |
Terminated 3 on June 04, 2008 |
Recall Number |
Z-0276-2008 |
Recall Event ID |
45326 |
510(K)Number |
K070292
|
Product Classification |
Prosthesis Resurfacing (Hip, Femoral) - Product Code KXA
|
Product |
Zimmer Durom Hip Resurfacing Systems, Femoral Component 46 Code L; Catalog No.: 01.00211.146, Lot 2376766. Zimmer, Warsaw, IN, 46581-0708. |
Code Information |
Lot 2376766. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E. Main St. Warsaw IN 46580-2304
|
For Additional Information Contact |
800-846-4637
|
Manufacturer Reason for Recall |
Mislabeled as to size; 54mm package contains 46 mm device and vice versa.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Zimmer GmbH notified Distributors via a Product Recall Notification letter, dated 9/26/07, instructing them to return the products and to subrecall. |
Quantity in Commerce |
5 |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = KXA and Original Applicant = ZIMMER GMBH
|