FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
- Recall number
- Z-2050-2014
- Recalling firm
- Zimmer, Inc.
- Product
- Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
- Status
- Terminated
- Initiated
- 2014-06-25
- Posted
- 2014-07-14
- Terminated
- 2014-10-30
- Reason
- Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
- Root cause
- Under Investigation by firm
- Action
- Recall notification letters sent to customers on 06/25/14. The recall letter, titled "URGENT DEVICE RECALL NOTICE", delivered to customers via a courier, with instructions for returning any unused affected product. The recall letter was accompanied with a response form and provided the following information to customers: product information with codes, reason for recall, risks, responsibilities, MedWatch Reporting and contacting information.
- Quantity
- 129 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
- 510(k) numbers
- ["K101880","K101977"]
- 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