Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER — Class II medical device recall Z-1290-2021
Terminated recall by Corin Ltd, reported 2021-03-31, distributed nationwide. The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers
| Recall number | Z-1290-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Corin Ltd, Cirencester, N/A, United Kingdom |
| Recall initiated | 2021-01-25 |
| Classified | 2021-03-22 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2022-11-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CO, DE, PL |
| Quantity | 23 units |
| Reason classes | labeling |
| Lot numbers | 464664 |
| Model numbers | 104.3215 |
Product
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
Reason for recall
The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers inside the packaging is incorrect: the Trinity Biolox Delta Ceramix Head 32XL is labeled as 36XL 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-1290-2021. 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.