Healing Abutment Conical Connection RP 0 3 — Class II medical device recall Z-2250-2020
Terminated recall by Nobel Biocare Usa Llc, reported 2020-06-10, distributed nationwide. Packaged dental implant healing abutments were found to contain the wrong size device.
| Recall number | Z-2250-2020 |
|---|---|
| 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 | 2019-05-28 |
| Classified | 2020-06-03 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2021-02-09 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 07332747034462 |
| Lot numbers | 13076845 |
| Model numbers | 36644 |
Product
Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.
Reason for recall
Packaged dental implant healing abutments were found to contain the wrong size device.
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-2250-2020. 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.