Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers, a medical device used for spinal procedures. The recall involves units with part number 1124.1115 and specific lot numbers including BAX159RE, BAX178JE, BAX208RE, BAX229UE, BAX250BE, BAX308BE, BAX347YE, and BAX351KE. The affected products were distributed worldwide.
The reason for the recall is that internal components of these specific implants may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. This deviation from the specified material composition is the basis for the corrective action.
The source text does not specify the number of units affected or report any illnesses or injuries. Consumers and healthcare providers should check their inventory for the specific part and lot numbers listed above. If the product matches the recalled description, it should be removed from use and returned to the manufacturer or a designated distributor in accordance with the recall instructions.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
- Manufacturer
- Globus Medical, Inc.
- Category
- Medical Device — Spinal Implants
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 22 recalled by Globus Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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