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 |
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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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