Device product
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Z-1711-2016
Product summary
- Event
- Event 73870
- Status
- Terminated
- Classification
- Class II
- Quantity
- 314 units
- Official record key
device-enforcement:Z-1711-2016
Official wording
Reason: Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Code information: Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
Distribution pattern: Distributed US (nationwide) and in Australia.
Derived failure modes
-
Unknown
Complaints of intra-operative breakage of the glenosphere impactors/extractors.