Medical device recalls Moderate risk

Wright Medical Technology, Inc. recalls ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

Recall date
November 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0563-2020
FDA classification
Class II
Brand / firm
Wright Medical Technology, Inc.
Sold / distributed
US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

Why it was recalled

The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

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