BEUDAMED
    FDA Recall Open, Classified

    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

    Recall: Z-0919-2025 · Initiated November 27, 2024

    Recall

    Recall Number
    Z-0919-2025
    Event Number
    95978
    Firm
    IsoTis OrthoBiologics, Inc.
    FEI Number
    3001503333
    Product Code
    MQV
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 27, 2024
    Posted
    January 15, 2025
    Address
    2 Goodyear, Ste A, Irvine, CA, 92618-2052

    Description

    OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

    Reason

    Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

    Action

    An Urgent Medical Device Recall notice dated 11/27/2024 was issued via email. The notice advises customers to discontinue use, review inventory on hand for the referenced lots, and return the affected part(s) to SeaSpine using the attached label to return the inventory. Once inventory has been returned, please acknowledge via DocuSign. Direct questions regarding this matter to Danielle Becker at [email protected] or Danielle Nelson-Archer at [email protected].

    Distribution

    US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.

    Quantity

    145