TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12
  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 Gmbh
Reason for Recall:
Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

TWIST DR 25X95MM Cann 12MM Thd 30MM AO; The twist drill is used to drill holes into bones/tissues for foot, ankle and hand implant systems.

Product Codes/Lot Numbers:

Part No.: 502015621; Lot Numbers: 8695/188B11, 8916/188B11, 9555/188D11, 10413/311A12, 11137/188B12

Distribution:

Distributed in: CO, IL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2321-2016

Related Recalls

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

Aug 8, 2024 Implants & Prosthetics Nationwide View Details →

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

Aug 8, 2024 Implants & Prosthetics Nationwide View Details →