Z-1794-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- April 30, 2021
- Termination Date
- July 28, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 products
Product Description
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.
Distribution Pattern
Domestic: VA, PA, IN.
Code Information
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