FDA Device recall Z-1234-2023
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis by Stryker Leibinger And Kg, citing device was shipped without having regulatory approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1234-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-06 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Leibinger And Kg |
| Distribution | MA |
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Reason
Device was shipped without having regulatory approval.
Identifiers
| code_info | TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0 |
|---|
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-1234-2023%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.