ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE
- 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, 10x26, 8-12mm, 8¿
Product Codes/Lot Numbers:
Part #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2851-2020
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