FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
- Recall number
- Z-0499-2010
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
- Status
- Terminated
- Initiated
- 2009-11-06
- Posted
- 2009-12-10
- Terminated
- 2010-10-08
- Reason
- The devices may not meet specifications, which may result in fracturing during tightening of the component.
- Root cause
- Process control
- Action
- User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.
- Quantity
- 738
- Distribution
- Ohio, Canada and France.
- Lot, serial or model codes
- Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.
- 510(k) numbers
- ["K061410"]
- PMA numbers
- not on file
- Product code
- DZE
- 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