Abutment Screw Retrieval Instrument 3 — Class II medical device recall Z-1322-2020
Terminated recall by Nobel Biocare Usa Llc, reported 2020-02-26, distributed nationwide. Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaran
| Recall number | Z-1322-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nobel Biocare Usa Llc, Yorba Linda, CA, United States |
| Recall initiated | 2019-03-14 |
| Classified | 2020-02-19 |
| Reported by FDA | 2020-02-26 |
| Terminated | 2024-02-15 |
| Distributed | Nationwide (US) |
| Quantity | 233 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 07332747084085 |
| Model numbers | 37503 |
Product
Abutment Screw Retrieval Instrument 3.0/NP - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.
Reason for recall
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
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-1322-2020. 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.