Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

Recall date
March 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1806-2025
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.

Why it was recalled

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

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

What was recalled

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

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