. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra… — Class II medical device recall Z-1101-2025
Ongoing recall by Nobel Biocare, reported 2025-02-12, distributed nationwide. Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may punct
| Recall number | Z-1101-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nobel Biocare, Goteborg, Sweden |
| Recall initiated | 2025-01-10 |
| Classified | 2025-02-05 |
| Reported by FDA | 2025-02-12 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07332747161731, 07332747161748, 07332747161755 |
| Lot numbers | 12253448, 12253620, 12253672, 12253673, 12254209, 12254213 |
| Model numbers | 300861, 300862, 300863 |
Product
. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function
Reason for recall
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
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-1101-2025. 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.