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. The hazard involves a material composition error in a medical implant, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x26, 9-13mm, 15¿, with Part # 1124.1032. The affected lots are identified by the following UDI/Lot numbers: BAX095XE, BAX175CE, BAX185BE, and BAX299LE. The product was distributed worldwide.
The reason for the recall is that internal components of the 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 provide specific instructions for consumers or patients regarding immediate actions to take, nor does it report any illnesses or injuries associated with the use of these specific lots. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
- Manufacturer
- Globus Medical, Inc.
- 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 (5)
- Part #: 1124.1032
- Lot # / UDI #: BAX095XE / (01)00889095069549(10)BAX095XE
- BAX175CE / (01)00889095069549(10)BAX175CE
- BAX185BE / (01)00889095069549(10)BAX185BE
- BAX299LE / (01)00889095069549(10)BAX299LE
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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