FDAFDA · Food and drugs·Recall number Z-1711-2016
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Published June 1, 2016 · Recall initiated: April 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Limacorporate S.p.A
- Distributor
- Distributed US (nationwide) and in Australia.
- Lot
- Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Italy
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