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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