FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
- Recall number
- Z-0444-2011
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Dental, Drill stop kit, REF DSKIT, for use with dental implants.
- Status
- Terminated
- Initiated
- 2010-05-18
- Posted
- 2010-11-23
- Terminated
- 2011-05-18
- Reason
- The instructions for use contain pre-vacuum sterilization instructions that may lead to compromised sterility at the lid-kit interface location.
- 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
- 158
- Distribution
- Distribution Nationwide, to France, and Spain.
- Lot, serial or model codes
- 61482528, 61484443, 61495269 and 61479592.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFY
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28