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U.S. Department of Health and Human Services

Class 2 Device Recall Durom cup

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 Class 2 Device Recall Durom cupsee related information
Date Initiated by FirmJuly 22, 2008
Date PostedSeptember 26, 2008
Recall Status1 Terminated 3 on October 21, 2009
Recall NumberZ-2416-2008
Recall Event ID 49079
510(K)NumberK053536 
Product Classification Hip Prosthesis - Product Code KWA
ProductZimmer Durom cup, Metasul Durom acetabular component, uncemented, 46/40, code F, Zimmer, Winterthur, Switzerland; REF 01.00214.146. 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
ActionA 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 Commerce19,014 of all products.
DistributionNationwide.
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 = KWA
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