Medical device recalls Moderate risk

Wright Medical Technology recalled over sterility concerns

Recall date
February 15, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Wright Medical Technology, Inc. recalls Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the O…
Recall number
Z-0786-2022
FDA classification
Class II
Brand / firm
Wright Medical Technology, Inc.
Sold / distributed
International distribution to the country of France.

Why it was recalled

An incorrect screw is packaged in the product, which contains a locking screw instead of a non-locking screw.

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

What was recalled

Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.

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