FDA Recall
Terminated
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Recall: Z-1711-2016
·
Initiated April 8, 2016
Recall
- Recall Number
- Z-1711-2016
- Event Number
- 73870
- Firm
- Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy
- FEI Number
- 3008021110
- Product Code
- KWS
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 8, 2016
- Terminated
- December 5, 2016
Description
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Reason
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Action
The affected firms received written notification to all distributors. The letter instructed the consignee to identify and remove all affected product in stock and return parts to Lima USA.
Distribution
Distributed US (nationwide) and in Australia.
Quantity
314 units