FDA Device recall Z-0160-2022
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
- FDA Device
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845 by Limacorporate S P A, citing there is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0160-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-01 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Limacorporate S P A |
| Distribution | US |
Product
REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
Reason
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Identifiers
| code_info | 2103825 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.