🔍 RecallPedia

Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

Class I - Dangerous
🏥 Medical Devices Recalled: July 23, 2014 Zimmer Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896
  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, Inc.
Reason for Recall:
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

Product Codes/Lot Numbers:

Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2227-2014

Related Recalls

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A

Zimmer

Class I - Dangerous

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Dec 2, 2025 Other Medical Devices Nationwide View Details →

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A

Zimmer

Class I - Dangerous

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Dec 2, 2025 Other Medical Devices Nationwide View Details →

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A

Zimmer

Class I - Dangerous

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Dec 2, 2025 Other Medical Devices Nationwide View Details →