FDA-Device2021-06-16Class II
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
Wishbone Medical, Inc.
Hazard
Nonconformities were discovered to the engineering specifications for implant plates and screws.
Sold states
Domestic: VA, PA, IN.
Affected count
60 products
Manufactured in
100 Capital Dr, N/A, Warsaw, IN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1794-2021Don't want to check this manually?
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