Recall Z-2009-2023 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Limacorporate S.p.A
REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
| Date | Jun 27, 2023 (initiated May 30, 2023) |
| Status | Open, Classified |
| Reason | Due to manufacturing issue, their is a potential for peripheral holes to be out of specification. |
| Root cause | Device Design |
| Action | On May 30, 2023 LimaCorporate issued an Urgent: Medical device Recall notification via E-Mail. LimaCorporate asked consignees to take the following actions: 1. Check your stock to locate and quarantine the affected devices. Devices must be sent back to your Lima local reference within 15 days together with a hard copy of the attached Response Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA 2. Fill out, sign and send the attached Response Form via email to your Lima local reference at uscomplaint@limacorporate.com as a confir |
| Quantity | 13 units |
| Distribution | US Nationwide distribution in the states of MI, IL, ND, MO, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222427 | PRIMA TT Glenoid Lima Corporate S.P.A., Oct 6, 2022 |