Date Initiated by Firm | July 22, 2008 |
Date Posted | September 26, 2008 |
Recall Status1 |
Terminated 3 on October 21, 2009 |
Recall Number | Z-2422-2008 |
Recall Event ID |
49079 |
510(K)Number | K053536 |
Product Classification |
Hip Prosthesis - Product Code KWA
|
Product | Zimmer Durom cup, Metasul Durom acetabular component, uncemented, 58/52, code R, Zimmer, Winterthur, Switzerland; REF 01.00214.158. The product is component of the Metasul LDH Head System intended for Noninflammatory degenerative joint disease. (Hip replacement) |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Zimmer Inc. 345 E Main St Warsaw IN 46580-2746
|
For Additional Information Contact | 866-946-5633 |
Manufacturer Reason for Recall | Instructions for use/surgical technique instructions are inadequate. |
FDA Determined Cause 2 | Labeling False and Misleading |
Action | A press release issued on 7/23/08. A letter was sent to implanting surgeons on 7/22/08 advising them of the problem and instructing them to stop implanting these devices until they receive training. Zimmer suspended all marketing and distribution in the U.S. pending completion of user training and revision of the instructions for surgical technique. Zimmer will conduct a removal of all copies of the current surgical technique document and replace it with revised surgical technique document(s). Contact Zimmer, Inc. at 1-866-946-5633 for assistance. Update: A dear surgeon letter was mailed 8/4/08 and provided patient management guidelines. A correction update was sent 8/16/08 with updated surgical technique and instructions for use documents. A dear surgeon letter was mailed 9/25/08 providing additional information regarding the training program. |
Quantity in Commerce | 19,014 of all products. |
Distribution | Nationwide. |
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 = KWA
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