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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer dental

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  Class 2 Device Recall Zimmer dental see related information
Date Initiated by Firm May 18, 2010
Date Posted November 23, 2010
Recall Status1 Terminated 3 on May 18, 2011
Recall Number Z-0444-2011
Recall Event ID 55889
Product Classification dental implant instrument - Product Code OFY
Product Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
Code Information 61482528, 61484443, 61495269 and 61479592.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
574-267-6131
Manufacturer Reason
for Recall		 The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.
FDA Determined
Cause 2		 Labeling design
Action Zimmer sent out "Urgent Device Correction" letters dated 5/18/2010. The consignees were provided with new instructions for use. The letter informed users that the current pre-vacuum cycle of 3 to 18 minutes is not enough time to assure sterility between the lid-kit interface and could lead to cross contamination of multiple patients. The users were informed that a pre-vacuum time of 30 minutes was required to assure sterility.
Quantity in Commerce 158
Distribution Distribution Nationwide, to France, and Spain.
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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