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 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870
FDA Recall Z-0726-2024 · Posted 2024-01-12
Recalling FirmLimacorporate S.p.A
Recall StatusOpen, Classified
Product CodeMBF
Date Initiated2023-08-29
Product Quantity179
Reason for Recall
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.
Firm 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 [email protected]
3) Customers with questions can email the firm at [email protected]
Root Cause
Device Design
Distribution Pattern
US: IL, MO, CA, IN, MI, OK
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.