Tapered Screw-Vent MTX Model TSVTB11 — Class II medical device recall Z-0284-2018
Terminated recall by Zimmer Dental Inc, reported 2017-12-27. Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing as
| Recall number | Z-0284-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2017-11-20 |
| Classified | 2017-12-21 |
| Reported by FDA | 2017-12-27 |
| Terminated | 2024-02-28 |
| Countries outside the US | CA, DE, ES, FR, IT |
| Quantity | 500 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00889024019935 |
| Lot numbers | 63519794 |
| Model numbers | TSVTB11 |
Product
Tapered Screw-Vent MTX Model TSVTB11
Reason for recall
Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.
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-0284-2018. 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.