BEUDAMED
    FDA Recall Terminated

    Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.

    Recall: Z-0561-04 · Initiated January 20, 2004

    Recall

    Recall Number
    Z-0561-04
    Event Number
    28213
    Firm
    Pioneer Surgical Technology
    FEI Number
    1000115331
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2004
    Posted
    February 27, 2004
    Terminated
    May 20, 2004
    Address
    375 River Park Cir, Marquette, MI, 49855-1781

    Description

    Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001.

    Reason

    Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.

    Action

    Zimmer was notified of this recall via letter dated 1/20/04 requesting Zimmer to remove all of this lot from inventory and from point of use locations.

    Distribution

    By Zimmer: Nationwide, Australia, Canada, Germany and United Kingdom.

    Quantity

    318