FDA Recall
Terminated
Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
Recall: Z-0444-2011
·
Initiated May 18, 2010
Recall
- Recall Number
- Z-0444-2011
- Event Number
- 55889
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- OFY
- Status
- Terminated
- Root Cause
- Labeling design
- Initiated
- May 18, 2010
- Posted
- November 23, 2010
- Terminated
- May 18, 2011
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
Reason
The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.
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.
Distribution
Distribution Nationwide, to France, and Spain.
Quantity
158