🔍 RecallPedia

ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

Class I - Dangerous
🏥 Medical Devices Recalled: October 15, 2014 DePuy Orthopaedics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 ABC4113 C4113 ABC50741 C50471 254400521 ABB13662 B13662 ABB19116 B19116 ABB19117 B19117 ABB19118 B19118 ABB35392 B35392 ABB35393 B35393 ABB39835 B39835 ABB41384 B41384 ABB46872 B46872 ABB49200 B49200 ABB50724 B50724 ABB55749 B55749 ABB63598 B63598 ABB66346 B66346 ABB72107 B72107 ABB77183 B77183 ABB79390 B79390 ABB79391 B79391 ABB80712 N80712 ABC17165 C17165 ABC5023 C5023
  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:
DePuy Orthopaedics, Inc.
Reason for Recall:
Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag

Product Codes/Lot Numbers:

Catalog NOs. 2544-00-521 and 2544-00-520; All lots are affected for the Device Correction. Lot numbers below should be inspected and swapped out if the bushing is incorrectly assembled: Part No. DePuy Synthes Lot No: MFG Lot No: 254400520 ABC22844 C22844 ABC22845 C22845 ABC34279 C34279 ABC34280 C34280 ABC4107 C4107 ABC4108 C4108 ABC4112 C4112 ABC4113 C4113 ABC50741 C50471 254400521 ABB13662 B13662 ABB19116 B19116 ABB19117 B19117 ABB19118 B19118 ABB35392 B35392 ABB35393 B35393 ABB39835 B39835 ABB41384 B41384 ABB46872 B46872 ABB49200 B49200 ABB50724 B50724 ABB55749 B55749 ABB63598 B63598 ABB66346 B66346 ABB72107 B72107 ABB77183 B77183 ABB79390 B79390 ABB79391 B79391 ABB80712 N80712 ABC17165 C17165 ABC5023 C5023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0199-2015

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