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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Dermacarriers II

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  Class 2 Device Recall Zimmer Dermacarriers II see related information
Date Initiated by Firm April 03, 2008
Date Posted July 30, 2008
Recall Status1 Terminated 3 on December 17, 2009
Recall Number Z-1550-2008
Recall Event ID 47334
Product Classification Skin Graft Expander - Product Code FZW
Product Zimmer Dermacarriers II skin graft carriers, 1.5 to 1 dermacarrier, Rx, latex free, sterile, Zimmer, Dover, Ohio; REF 00-2195-012-00.
Single use device for use during skin grafting procedures.
Code Information All lots.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
330-343-8801
Manufacturer Reason
for Recall		 Sterility compromised. Lack of assurance of sterility, as the packages may not have been sealed on the manufacturer's end.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were notified via letter (Urgent: Medical Device Correction) dated 4/3/08 to identify their stocks on hand, verify package sealing, to discard any non-sealed packages, mail the Business Reply Card regardless if there are any remaining affected products.
Quantity in Commerce 99345 of all units
Distribution Worldwide Distribution --- including USA and countries of Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, Ecuador, England, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Iraq, Israel, Italy, Japan, Jordan, Kenya, Largos, Lebanon, Lithuania, Malta, Mexico, Morocco, Netherlands, Nigeria, Panama, Peru, Poland, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunis, Turkey and Venezuela.
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.
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