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Terminated

Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.

FDA Recall Z-0444-2011 · Posted 2010-11-23

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeOFY
Date Initiated2010-05-18
Date Terminated2011-05-18
Product Quantity158

Reason for Recall

The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Distribution Nationwide, to France, and Spain.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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