Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)
  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:
Medacta Usa Inc
Reason for Recall:
Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.

Product Codes/Lot Numbers:

Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243)

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0267-2013

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