CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/R This device is indicated for patients with severe knee pain and disability
Class I - DangerousWhat Should You Do?
- Check if you have this product: 00-5972-015-01 61777593 00-5972-018-02 4002192 00-5970-012-02 61878272 00-5970-013-02 61777576 00-5970-013-02 62135909 00-5970-014-02 11400192 00-5970-014-02 62122787 00-5970-014-02 62135920 00-5970-014-02 62132399 00-5970-014-02 62132399R 00-5970-014-02 62135921 00-5970-015-02 11002229 00-5970-015-02 61777581 00-5970-015-02 62135936 00-5970-016-02 61777583 00-5970-016-02 62128113 00-5970-017-01 11003049 00-5970-018-01 61758971 00-5970-018-01 11003323 00-5970-018-02 11003330 00-5970-018-02 11003322
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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 Biomet, Inc.
- Reason for Recall:
- The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly polished surface, leaving residue or material from the LDPE bag on the implant after it is removed from the bag.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CR PRECOAT FEM COMP SIZE BMR CR PRECOAT FEM COMP SIZE C/R CR PRECOAT FEM COMP SIZE D/R CR PRECOAT FEM COMP SIZE E/R CR PRECOAT FEM COMP SIZE F/R CR PRECOAT FEM COMP SIZE G/L CR PRECOAT FEM COMP SIZE H/L CR PRECOAT FEM COMP SIZE H/R CR POROUS FEM COMP SIZE E/L CR POROUS FEM COMP SIZE H/R This device is indicated for patients with severe knee pain and disability
Product Codes/Lot Numbers:
00-5972-015-01 61777593 00-5972-018-02 4002192 00-5970-012-02 61878272 00-5970-013-02 61777576 00-5970-013-02 62135909 00-5970-014-02 11400192 00-5970-014-02 62122787 00-5970-014-02 62135920 00-5970-014-02 62132399 00-5970-014-02 62132399R 00-5970-014-02 62135921 00-5970-015-02 11002229 00-5970-015-02 61777581 00-5970-015-02 62135936 00-5970-016-02 61777583 00-5970-016-02 62128113 00-5970-017-01 11003049 00-5970-018-01 61758971 00-5970-018-01 11003323 00-5970-018-02 11003330 00-5970-018-02 11003322
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1041-2018
Related Recalls
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Zimmer Biomet
Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
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