Recall Z-0726-2024 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Limacorporate S.p.A
PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED
| Date | Jan 12, 2024 (initiated Aug 29, 2023) |
| Status | Open, Classified |
| Reason | Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position. |
| Root cause | Device Design |
| Action | On 8/29/23, the firm phoned all agents and surgeons to immediately stop surgeries with affected devices. On 10/10/23 the firm emailed recall notices to customers asking them to take the following actions: 1) Surgeons are suggested to perform a short-term patient s monitoring (radiographs at 6 weeks, 3-6 months and 1 year might be considered) and acting accordingly, based on a case-by-case evaluation. 2) Locate, quarantine, and return affected devices. Complete and return the response form to uscomplaint@limacorporate.com 3) Customers with questions can email the firm at medicalcomplaints@lim |
| Quantity | 179 |
| Distribution | US: IL, MO, CA, IN, MI, 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 |