Medical device recalls Moderate risk

Limacorporate S.p.A recalls SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

Recall date
April 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1711-2016
FDA classification
Class II
Brand / firm
Limacorporate S.p.A
Sold / distributed
Distributed US (nationwide) and in Australia.

Why it was recalled

Complaints of intra-operative breakage of the glenosphere impactors/extractors.

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 glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

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