Wishbone Medical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1794-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: April 30, 2021

Date Posted: June 16, 2021

Recall Number: Z-1794-2021

Event ID: 87940

Reason for Recall:

Nonconformities were discovered to the engineering specifications for implant plates and screws.

Status: Terminated

Product Quantity: 60 products

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

Distribution Pattern:

Domestic: VA, PA, IN.

Voluntary or Mandated:

Voluntary: Firm initiated