Temporary Titanium Abutments — Class II medical device recall Z-1111-2025
Ongoing recall by DDS Lab, reported 2025-02-12, distributed nationwide. Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder)
| Recall number | Z-1111-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DDS Lab, Tampa, FL, United States |
| Recall initiated | 2024-12-06 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 11,259 |
| Reason classes | device malfunction |
Product
Temporary Titanium Abutments
Reason for recall
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
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-1111-2025. 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.