BEUDAMED
    FDA Recall Open, Classified

    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

    Recall: Z-0726-2024 · Initiated August 29, 2023

    Recall

    Recall Number
    Z-0726-2024
    Event Number
    93668
    Firm
    Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy
    FEI Number
    3008021110
    Product Code
    MBF
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    August 29, 2023
    Posted
    January 12, 2024

    Description

    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

    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.

    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]

    Distribution

    US: IL, MO, CA, IN, MI, OK

    Quantity

    179