ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part #: 1124.1115; Lot # / UDI #: BAX159RE / (01)00889095069716(10)BAX159RE; BAX178JE / (01)00889095069716(10)BAX178JE; BAX208RE / (01)00889095069716(10)BAX208RE; BAX229UE / (01)00889095069716(10)BAX229UE; BAX250BE / (01)00889095069716(10)BAX250BE; BAX308BE / (01)00889095069716(10)BAX308BE; BAX347YE / (01)00889095069716(10)BAX347YE; BAX351KE / (01)00889095069716(10)BAX351KE
- 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:
- Globus Medical, Inc.
- Reason for Recall:
- Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Product Codes/Lot Numbers:
Part #: 1124.1115; Lot # / UDI #: BAX159RE / (01)00889095069716(10)BAX159RE; BAX178JE / (01)00889095069716(10)BAX178JE; BAX208RE / (01)00889095069716(10)BAX208RE; BAX229UE / (01)00889095069716(10)BAX229UE; BAX250BE / (01)00889095069716(10)BAX250BE; BAX308BE / (01)00889095069716(10)BAX308BE; BAX347YE / (01)00889095069716(10)BAX347YE; BAX351KE / (01)00889095069716(10)BAX351KE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2861-2020
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