Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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, Inc.
- Reason for Recall:
- Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.
Product Codes/Lot Numbers:
Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1465-2013
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