Recall Z-1711-2016 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Limacorporate S.p.A
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
| Date | Apr 8, 2016 |
| Status | Terminated |
| Reason | Complaints of intra-operative breakage of the glenosphere impactors/extractors. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 314 units |
| Distribution | Distributed US (nationwide) and in Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110598 | SMR REVERSE SHOULDER SYSTEM Lima Corporate S.P.A., Aug 18, 2011 |