BEUDAMED
    FDA Recall Terminated

    Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMORAL HEAD 2 801802604 12/14 COCR FEMORAL HEAD 2 801802605 12/14 COCR FEMORAL HEAD 2 801802801 12/14 COCR FEMORAL HEAD 2 801802802 12/14 COCR FEMORAL HEAD 2 801802803 12/14 COCR FEMORAL HEAD 2 801802805 12/14 COCR FEMORAL HEAD 2 801802814 12/14 COCR FEMORAL HEAD 2 801803201 12/14 COCR FEMORAL HEAD 3 801803202 12/14 COCR FEMORAL HEAD 3 801803203 12/14 COCR FEMORAL HEAD 3 801803205 12/14 COCR FEMORAL HEAD 3 801803214 12/14 COCR FEMORAL HEAD 3 801803601 12/14 COCR FEMORAL HEAD 3 801803602 12/14 COCR FEMORAL HEAD 3 801803603 12/14 COCR FEMORAL HEAD 3 801803604 12/14 COCR FEMORAL HEAD 3 801803605 12/14 COCR FEMORAL HEAD 3 801804001 12/14 COCR FEMORAL HEAD 4 801804002 12/14 COCR FEMORAL HEAD 4 801804003 12/14 COCR FEMORAL HEAD 4 801804004 12/14 COCR FEMORAL HEAD 4 902602100 6 DEGREE COCR FEM HEAD 22 32902603935 FEM HD 26MMDIA SHT NK+ 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty

    Recall: Z-1100-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-1100-2016
    Event Number
    72900
    FEI Number
    1000132037
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 11, 2016
    Posted
    March 12, 2016
    Terminated
    April 13, 2017
    Address
    Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4, Mercedita, PR, 00715

    Description

    Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR FEMORAL HEAD 2 801802604 12/14 COCR FEMORAL HEAD 2 801802605 12/14 COCR FEMORAL HEAD 2 801802801 12/14 COCR FEMORAL HEAD 2 801802802 12/14 COCR FEMORAL HEAD 2 801802803 12/14 COCR FEMORAL HEAD 2 801802805 12/14 COCR FEMORAL HEAD 2 801802814 12/14 COCR FEMORAL HEAD 2 801803201 12/14 COCR FEMORAL HEAD 3 801803202 12/14 COCR FEMORAL HEAD 3 801803203 12/14 COCR FEMORAL HEAD 3 801803205 12/14 COCR FEMORAL HEAD 3 801803214 12/14 COCR FEMORAL HEAD 3 801803601 12/14 COCR FEMORAL HEAD 3 801803602 12/14 COCR FEMORAL HEAD 3 801803603 12/14 COCR FEMORAL HEAD 3 801803604 12/14 COCR FEMORAL HEAD 3 801803605 12/14 COCR FEMORAL HEAD 3 801804001 12/14 COCR FEMORAL HEAD 4 801804002 12/14 COCR FEMORAL HEAD 4 801804003 12/14 COCR FEMORAL HEAD 4 801804004 12/14 COCR FEMORAL HEAD 4 902602100 6 DEGREE COCR FEM HEAD 22 32902603935 FEM HD 26MMDIA SHT NK+ 32902603800 FEMORAL HEAD +0.5 X 22 MM 32902604810 FEMORAL HEAD +3.5 X 22 MM 32902604845 FEMORAL HEAD +7.0 X 22 MM For use in total or hemi hip arthroplasty

    Reason

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to [email protected]. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.

    Distribution

    US Nationwide Distribution

    Quantity

    35,032