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Limacorporate S.p.A recalls SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Recalled June 1, 2016 · FDA recall Z-1711-2016 · Limacorporate S.p.A
Hazard
Complaints of intra-operative breakage of the glenosphere impactors/extractors. · FDA Class II
Units
314 units
Sold at
Distributed US (nationwide) and in Australia.
Description
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Product
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Manufacturer(s)
Limacorporate S.p.A
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →