Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

Recall date
May 30, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2624-2017
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US distribution to TN

Why it was recalled

The incorrect Loctite adhesive was used to assemble the impactor heads.

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

What was recalled

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

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