Medical device recalls Moderate risk

Limacorporate S.p.A recalls SMR allen wrench 5 mm, product code 9013.50.210

Recall date
July 21, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2707-2016
FDA classification
Class II
Brand / firm
Limacorporate S.p.A
Sold / distributed
US, Italy, Australia

Why it was recalled

Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.

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

What was recalled

SMR allen wrench 5 mm, product code 9013.50.210

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