REF 8420 — Class II medical device recall Z-0160-2022
Terminated recall by Limacorporate S.p.A, reported 2021-10-27, distributed nationwide. There is a potential that the length of bone screws identified on labeling may not correspond to the actual le
| Recall number | Z-0160-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Limacorporate S.p.A, San Daniele Del Friuli, N/A, Italy |
| Recall initiated | 2021-10-01 |
| Classified | 2021-10-21 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2024-06-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DE, ES, HR, IE, IT, JP, KR, PL, PT, SE, SI, SK |
| Quantity | 200 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08033390018845 |
| Model numbers | 8420.15.010 |
Product
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Reason for recall
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
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-0160-2022. 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.