🔍 RecallPedia

Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty

Class I - Dangerous
🏥 Medical Devices Recalled: January 11, 2016 Zimmer Manufacturing B.V. Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    lot no.: 61674472 61906696 62016799 62332483 61674473 61902194 61906697 62326386 61674476 61953546 62161131 62172656 62326385 61953547 62011539 62017894 62130757 61886072 61953548 62017895 62172659 61886073 61948763 61953551 62172661 61874793 61948764 61996232 62017897 62172663 61874794 61953554 62286122
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Zimmer Manufacturing B.V.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Product 33 consists of all product under product code: JDI and same usage: Item no: 662406515 HGP II ACETABULAR CUP BON 662406520 HGP II ACETABULAR CUP BON 662406525 HGP II ACETABULAR CUP BON 662406530 HGP II ACETABULAR CUP BON 662406535 HGP II ACETABULAR CUP BON 662406540 HGP II ACETABULAR CUP BON 662406550 HGP II ACETABULAR CUP BON 662406560 HGP II ACETABULAR CUP BON For use in total hip arthroplasty

Product Codes/Lot Numbers:

lot no.: 61674472 61906696 62016799 62332483 61674473 61902194 61906697 62326386 61674476 61953546 62161131 62172656 62326385 61953547 62011539 62017894 62130757 61886072 61953548 62017895 62172659 61886073 61948763 61953551 62172661 61874793 61948764 61996232 62017897 62172663 61874794 61953554 62286122

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1131-2016

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