Outer Package Label: Tapered Screw-Vent Implant System — Class II medical device recall Z-2963-2018
Terminated recall by Zimmer Dental Inc, reported 2018-09-12, distributed nationwide. Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbe
| Recall number | Z-2963-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Dental Inc, Carlsbad, CA, United States |
| Recall initiated | 2018-05-10 |
| Classified | 2018-08-31 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2020-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BG, CA, DE, ES, FR, HR, IT, PT |
| Quantity | 299 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00889024019508, 00889024019621 |
| Lot numbers | 63773888, 63781164 |
| Model numbers | TSVB10, TSVM4B10 |
Product
Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental 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. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Reason for recall
Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.
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-2963-2018. 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.