Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
FDA device recall Z-0444-2011 · posted 2010-11-23 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- OFY
- Quantity affected
- 158
- Distribution
- Distribution Nationwide, to France, and Spain.
- Date initiated
- 2010-05-18
- Date posted
- 2010-11-23
- Date terminated
- 2011-05-18
- Location
- Warsaw, IN
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