FDA-Device2016-06-01Class II
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Limacorporate S.p.A
Hazard
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Sold states
Distributed US (nationwide) and in Australia.
Affected count
314 units
Manufactured in
Via Nazionale 52, N/A, San Daniele Del Friuli, N/A, Italy
Products
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1711-2016Don't want to check this manually?
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