FDA Device recall Z-1794-2021
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut
- FDA Device
- Class II
- terminated
- Published 2021-06-16
On 2021-06-16 the FDA classified a Class II recall of WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut by Wishbone Medical, citing nonconformities were discovered to the engineering specifications for implant plates and screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1794-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-04-30 |
| Published | 2021-06-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wishbone Medical |
| Distribution | IN, PA, VA |
Product
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
Reason
Nonconformities were discovered to the engineering specifications for implant plates and screws.
Identifiers
| code_info | Lot Number: 20837, 124555, 124557, 124558, 124557, 124556, 124555, 124554, 124553, 124552, 124551, 124550, 124548, 1245…Lot Number: 20837, 124555, 124557, 124558, 124557, 124556, 124555, 124554, 124553, 124552, 124551, 124550, 124548, 124547, 124546, 124545, 124636, 124634, 124632, 124631, 124630, 22571, 20846, 20845, 20844, 20842, 24092, 22461, 24287, 24091, 24282, 22462, 22463, 24090, 24289, 20837, 22464, 24284, 22465, 22014, 24285, 22554, 22466, 22196, 24292, 22529, 24085, 22195, 22469, 24291, 22553, 24083, 24087, 22470, 24283, 22560, 24082, 24088, 124630, 134631, 124632, 134633, 124634, 124636, 124545, 124546, 124547, 124548, 124550, 125678, 124551, 126058, 124552, 125677, 124553, 125675, 124554, 124555, 125451, 124556, 125452, 124557, 125453, 124558, 125454 |
|---|
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-1794-2021%22
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