🔍 RecallPedia

Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 For use in total or hemi 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.: 62222763 62240266 62268561 62284487 62294353 62310467 62320160 62346566 61846909 61859930 62028715 62069012 62114832 62237560 62278694 62284486 62298294 62305946 62310463 62330767 62340043 61864095 62028713 62038326 62086042 62100678 62114831 62215704 62284488 62291943 62305945 62311644 62317919 62320157 62320158 62340044 62363364 61866237 62105184 62215705 62268566 62284489 62294354 62303512 62311645 62330768 62065287 62211913 62268563 62284490 62299091 62320161 62333990 62299091N 61885871 62100679 62278695 62303703 62333992 62069011 62280472
  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 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 For use in total or hemi hip arthroplasty

Product Codes/Lot Numbers:

lot no.: 62222763 62240266 62268561 62284487 62294353 62310467 62320160 62346566 61846909 61859930 62028715 62069012 62114832 62237560 62278694 62284486 62298294 62305946 62310463 62330767 62340043 61864095 62028713 62038326 62086042 62100678 62114831 62215704 62284488 62291943 62305945 62311644 62317919 62320157 62320158 62340044 62363364 61866237 62105184 62215705 62268566 62284489 62294354 62303512 62311645 62330768 62065287 62211913 62268563 62284490 62299091 62320161 62333990 62299091N 61885871 62100679 62278695 62303703 62333992 62069011 62280472

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1117-2016

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