Spline Twist Implant — Class II medical device recall Z-0153-2015
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-0153-2015 |
|---|---|
| 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 | 61792330 |
| Model numbers | 2135 |
Product
Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement.
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-0153-2015. 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.