FDA Device recall Z-0316-2022
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
- FDA Device
- Class II
- terminated
- Published 2021-12-08
On 2021-12-08 the FDA classified a Class II recall of INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS by Wright Medical Technology, citing the package contents and package labeling do not match.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0316-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-04 |
| Published | 2021-12-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wright Medical Technology |
| Distribution | US |
Product
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Reason
The package contents and package labeling do not match.
Identifiers
| code_info | Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033) |
|---|
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-0316-2022%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.