WishBone Medical Plate and Screw System — Class II medical device recall Z-1794-2021
Terminated recall by Wishbone Medical, Inc., reported 2021-06-16, distributed in IN, PA, VA. Nonconformities were discovered to the engineering specifications for implant plates and screws.
| Recall number | Z-1794-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wishbone Medical, Inc., Warsaw, IN, United States |
| Recall initiated | 2021-04-30 |
| Classified | 2021-06-04 |
| Reported by FDA | 2021-06-16 |
| Terminated | 2022-07-28 |
| Distributed | IN, PA, VA |
| Quantity | 60 products |
| Lot numbers | 124545, 124546, 124547, 124548, 124550, 124551, 124552, 124553, 124554, 124555, 124556, 124557, 124558, 124630, 124631, 124632, 124634, 124636, 125451, 125452, 125453, 125454, 125675, 125677, 125678, 126058, 134631, 134633, 20837, 20842, 20844, 20845, 20846, 22014, 22195, 22196, 22461, 22462, 22463, 22464 and 25 more |
| Model numbers | PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US |
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 for recall
Nonconformities were discovered to the engineering specifications for implant plates and screws.
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-1794-2021. 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.