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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