—#92220

Product

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

FDA product code: OFY — Dental Implant Surgical Tray
Device class: Class 1
Medical specialty: Dental
Affected lot / code info: 61482528, 61484443, 61495269 and 61479592.

Why it was recalled

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

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Distribution Nationwide, to France, and Spain.

Timeline

Recall initiated: 2010-05-18
Posted by FDA: 2010-11-23
Terminated: 2011-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.