Medical device recalls Moderate risk

Wishbone Medical, Inc. recalls WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-…

Recall date
April 30, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1794-2021
FDA classification
Class II
Brand / firm
Wishbone Medical, Inc.
Sold / distributed
Domestic: VA, PA, IN.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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