FDA recall Z-1794-2021

Wishbone Medical, Inc. · Class II · device

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.

Distribution

Domestic: VA, PA, IN.

Key facts

Status: Terminated
Initiation date: 2021-04-30
Report date: 2021-06-16
Termination date: 2022-07-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2021