16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part Number 399.56 Lot Numbers T106341
  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:
Synthes (USA) Products LLC
Reason for Recall:
It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.

Product Codes/Lot Numbers:

Part Number 399.56 Lot Numbers T106341

Distribution:

Distributed in: US, NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV, KS

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2086-2015

Related Recalls

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Sep 26, 2025 Other Medical Devices Nationwide View Details →

Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.

Sep 26, 2025 Other Medical Devices Nationwide View Details →