Corin BIOLOX DELTA MOD HEAD — Class II medical device recall Z-0727-2023
Ongoing recall by Corin Ltd, reported 2022-12-28, distributed nationwide. The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
| Recall number | Z-0727-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Corin Ltd, Cirencester, United Kingdom |
| Recall initiated | 2022-11-08 |
| Classified | 2022-12-19 |
| Reported by FDA | 2022-12-28 |
| Distributed | Nationwide (US) |
| Quantity | 12 units |
| Lot numbers | 503151 |
| Model numbers | 104.3615 |
Product
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Reason for recall
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
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-0727-2023. 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.