FDA Device recall Z-0727-2023
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
- FDA Device
- Class II
- ongoing
- Published 2022-12-28
On 2022-12-28 the FDA classified a Class II recall of Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615 by Corin, citing the BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0727-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-08 |
| Published | 2022-12-28 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Corin |
| Distribution | US |
Product
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
Reason
The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.
Identifiers
| code_info | UDI/DI (01) 0 5055196 96834, Lot 503151 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0727-2023%22
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