Z-1711-2016 Class II Terminated

Recalled by Limacorporate S.p.A — San Daniele Del Friuli, N/A

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