Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part Numbers: 11-104212 & 11-104211;Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.
- 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 hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Product Codes/Lot Numbers:
Part Numbers: 11-104212 & 11-104211;Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1754-2015
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