Tapered Screw-Vent recallZ-1190-2018 · Zimmer Dental Inc · initiated Nov 29, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer Dental Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-1190-2018
- Status
- Terminated
- Initiated by the company
- Nov 29, 2017
- Posted by the FDA
- Mar 5, 2018
- Recalling firm
- Zimmer Dental Inc
- Quantity
- 995 distribution events total
- Product code
- DZE
- FDA submissions
- K072589
- Distribution
- Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.
Product description
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.
Code information (models, lots, serial numbers)
Lot No. 63619437, UDI #(01)00889024019225 (17)220331 (10)63619437.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tapered Screw-Vent TSV4B10ZimVie US Corp LLC · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall562 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 78667).
- Z-1189-2018 · TerminatedTapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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