Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All product manufactured prior to January 2014.
  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 Biomet, Inc.
Reason for Recall:
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Various Surgical Instruments: Screws and Reamers, Item Nos. 00579104100 00579104200 00579104300 00579104400 00579105400 00597909526 00597909529 00597909532 00597909535 00597909538 00597909541 00597909546 00597909551 00598304027 00598304033 00598304048 00598304148

Product Codes/Lot Numbers:

All product manufactured prior to January 2014.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0322-2020

Related Recalls

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.

Nov 17, 2020 Other Medical Devices Nationwide View Details →