Tapered Screw-Vent Implant — Class II medical device recall Z-0154-2015
Terminated recall by Zimmer Dental Inc, reported 2014-11-05, distributed nationwide. Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the
| Recall number | Z-0154-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2014-10-01 |
| Classified | 2014-10-30 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, CR, ES, FR, IL, IT, JP, MA, PL |
| Quantity | 1,044 units |
| Lot numbers | 62658448, 62659204 |
| Model numbers | TSV4B10, TSV4B11 |
Product
Tapered Screw-Vent Implant, MTX, 4.1mmD X 10mmL X 3.5mm Platform Part No. TSV4B10 Tapered Screw-Vent Implant, MTX, 4.1mmD X 11.5mmL X 3.5mm Platform Part No. TSV4B11 The Tapered Screw-Vent Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth
Reason for recall
Zimmer Dental is recalling Tapered Screw-Vent Implants because the incorrect diameter size was printed on the inner vial.
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-0154-2015. 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.