BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A

    Recall: Z-2222-2025 · Reported August 6, 2025

    Enforcement

    Recall Number
    Z-2222-2025
    Event ID
    97126
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Osteotec Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 6, 2025
    Initiation Date
    June 18, 2025
    Classification Date
    July 31, 2025
    Address
    Unit 9, Silver Business Park; Airfield Way, Christchurch, N/A, United Kingdom

    Description

    Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number: OSTF-3 (Sz. 3), OSTF-4 (Sz. 4), OSTF-5 (Sz. 5) Software Version: N/A Product Description: The Osteotec Silicone Finger Implant is a one-piece, sterile, flexible silicone elastomer implant which is placed, during arthroplasty, in the proximal and distal intramedullary canals of either metacarpophalangeal (MCP) or proximal interphalangeal (PIP) joints. The implant is not fixed into the bones and becomes stabilized by the encapsulation process. The implant is available in eleven sizes to meet various anatomical variations and is supplied sterile. Component: N/A

    Reason

    There is the potential that the silicone implant may contain foreign material

    Code Info

    Lot Code: OSTF-3 LOT 127707 Exp 07/17/2028, UDI-DI:5060183090040 OSTF-4 LOT 127708 Exp 07/17/2028, UDI-DI:5060183090057 OSTF-5 LOT 127709 Exp 07/17/2028, UDI-DI:5060183090064

    Distribution

    US Nationwide distribution in the state of CA.

    Quantity

    15573 units