Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
- 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:
- Howmedica Osteonics Corp.
- Reason for Recall:
- A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
Product Codes/Lot Numbers:
Catalog Number: C-MM100434-00; Lot Number: HX2H9A;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2732-2024
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Howmedica Osteonics
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
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