Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
- 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:
- Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Product Codes/Lot Numbers:
Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1512-2018
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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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Howmedica Osteonics
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
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