Z-1711-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 1, 2016
- Initiation Date
- April 8, 2016
- Termination Date
- December 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 314 units
Product Description
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Reason for Recall
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Distribution Pattern
Distributed US (nationwide) and in Australia.
Code Information
Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600