🔍 RecallPedia

Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.

Class I - Dangerous
🏥 Medical Devices Recalled: July 27, 2012 Biomet U.K. Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.
  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:
Biomet U.K., Ltd.
Reason for Recall:
A drafting error during an unrelated design change has led to 4 misleading dimensions on the drawing. The CAD model remained the same thickness but the problem dimensions were accidentally struck from an incorrect point result in an increase of 1.0mm in the value of each dimension
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Oxford Gap Gauge SML 3/4mm. The instrument is used for an intermediate check of the flexion and extension gaps when preparing the femur to accept the femoral component.

Product Codes/Lot Numbers:

Catalog Number: 32-422801 and Lot Number Identification: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201.

Distribution:

Distributed in: IN, SD, TX, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2224-2012

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