ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part #: 1124.1111; Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME; BAX156NE / (01)00889095069679(10)BAX156NE; BAX167PE / (01)00889095069679(10)BAX167PE; BAX229VE / (01)00889095069679(10)BAX229VE; BAX290TE / (01)00889095069679(10)BAX290TE; BAX290UE / (01)00889095069679(10)BAX290UE; BAX294WE / (01)00889095069679(10)BAX294WE; BAX376DE / (01)00889095069679(10)BAX376DE; BAX376CE / (01)00889095069679(10)BAX376CE
- 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, 8-12mm, 8¿
Product Codes/Lot Numbers:
Part #: 1124.1111; Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME; BAX156NE / (01)00889095069679(10)BAX156NE; BAX167PE / (01)00889095069679(10)BAX167PE; BAX229VE / (01)00889095069679(10)BAX229VE; BAX290TE / (01)00889095069679(10)BAX290TE; BAX290UE / (01)00889095069679(10)BAX290UE; BAX294WE / (01)00889095069679(10)BAX294WE; BAX376DE / (01)00889095069679(10)BAX376DE; BAX376CE / (01)00889095069679(10)BAX376CE
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2858-2020
Related Recalls
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Globus Medical
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Globus Medical
Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation, local toxicity, systemic toxicity, sensitivity, and cross-contamination.
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.