Medical device recalls Moderate risk

Wright Medical Technology, Inc. recalls ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

Recall date
February 2, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1169-2023
FDA classification
Class II
Brand / firm
Wright Medical Technology, Inc.
Sold / distributed
US Nationwide distribution in the state of NY.

Why it was recalled

Stryker has identified an issue that impacts two specific lots of CLAW" II plates. The plates within these two lots were found to have been comingled, resulting in the incorrect product in packages. Packaging for 402S0425 incorrectly contained 40241425, and vice versa.

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

What was recalled

ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device

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