BEUDAMED
    FDA Recall Terminated

    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033.

    Recall: Z-1625-2010 · Initiated June 5, 2009

    Recall

    Recall Number
    Z-1625-2010
    Event Number
    52527
    Firm
    Endotec, Inc.
    FEI Number
    3004553437
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 5, 2009
    Posted
    May 20, 2010
    Terminated
    October 22, 2013
    Address
    2546 Hansrob Rd, Orlando, FL, 32804-3318

    Description

    Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III Ankle Bearing Catalog: 05-13-0732, 8x3mm F-P Type III Ankle Bearing Catalog: 05-13-0533, 8x1mm F-P Type III Ankle Bearing Catalog: 05-13-0731. BP Ankle System, F-P Type III Tibial Ankle Component: Size 1 F-P Type III Tibial Component Catalog: 05-12-0031, Size 2 F-P Type III Tibial Component Catalog: 05-12-0032, Size 3 F-P Type III Tibial Component Catalog: 05-12-0033. BP Ankle System, F-P Type III Talar Component: Size 1 F-P Type III Talar Component Catalog: 05-01-0031, Size 2 F-P Type III Talar Component Catalog: 05-01-0032, Size 3 F-P Type III Talar Component Catalog: 05-01-0033.

    Reason

    Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

    Action

    Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.

    Distribution

    Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.

    Quantity

    50 Pieces