Reported Jun 1, 2016 · Terminated
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli, N/A · N/A
Is this the product you have?
- SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
- Lot codes and dates
- Lot numbers
139076314AA09414AA43114AA52815AA09415AA55715AA55815AA55915AA600
- Lot numbers
- Amount recalled
- 314 units
Where it was sold
- Nationwide
Why it was recalled
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
This product could cause temporary or reversible health problems — stop using it.
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