FDA Medical Device Recalls (openFDA)
Zimmer Dental Inc: Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
- Recall number
- Z-1190-2018
- Recalling firm
- Zimmer Dental Inc
- Product
- Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
- Status
- Terminated
- Initiated
- 2017-11-29
- Posted
- 2018-03-05
- Terminated
- 2019-02-08
- Reason
- Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
- Root cause
- Packaging process control
- Action
- On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.
- Quantity
- 995 distribution events total
- Distribution
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
- Lot, serial or model codes
- Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
- 510(k) numbers
- ["K072589"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 1038806
- Firm city
- Carlsbad
- Firm state
- CA
- 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