Tapered Screw-Vent MTX — Class II medical device recall Z-1189-2018
Terminated recall by Zimmer Dental Inc, reported 2018-04-04, distributed nationwide. Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently comming
| Recall number | Z-1189-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-03-26 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, CR, DK, ES, FR, HU, IT, JP, LB, PT, RS, TW |
| Quantity | 995 distribution |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024019928 |
| Lot numbers | 63621027 |
| Model numbers | TSVTB10 |
Product
Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSVTB10.
Reason for recall
Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1189-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.