🔍 RecallPedia

I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.

Class I - Dangerous
🏥 Medical Devices Recalled: November 12, 2014 DePuy Orthopaedics Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS
  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:
Use of excessive force when impacting may lead to intra-operative femoral fracture.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

I.M. Hole Locator Instrument. Orthopedic manual surgical instrument. The IM Hole locator guides the IM drill during IM Hole preparation. The instrument is positioned between the condyles and aligned with the anatomical axis. Pins can be placed in the IM hole locator to assist with additional stability. The drill bush may also be lightly impacted onto the distal femur for additional stability.

Product Codes/Lot Numbers:

CATALOG NO. : 9505-01-041 Barcode GTIN: 10603295224389 ALL LOTS

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0908-2015

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