Recall Z-1317-2023 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Limacorporate S.p.A
SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
| Date | Apr 1, 2023 (initiated Feb 21, 2023) |
| Status | Open, Classified |
| Reason | Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation. |
| Root cause | Process control |
| Action | On 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to pms@limacorporate.com 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to medicalcomplaints@limacorporate.com |
| Quantity | 1 |
| Distribution | US: MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163397 | SMR Hybrid Glenoid System Lima Corporate S.P.A., Jun 29, 2017 |