Z-0444-2011

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

Name: Z-0444-2011 Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants
Creator: Zimmer Inc.
Published: 2010-05-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-05-18 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants on 2010-05-18. The reason FDA records is "The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0444-2011
Status: Terminated
Initiated: 2010-05-18
Posted: 2010-11-23
Terminated: 2011-05-18
Recalling firm: Zimmer GmbH
Product: Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
Product code: OFY Dental Implant Surgical Tray
Reason for recall: The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: 61482528, 61484443, 61495269 and 61479592.

Product code OFY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)