FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect
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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or structural defects (material substitution in an implant) are rated as Severe (4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific lots of ALTERA Spacers manufactured by Globus Medical, Inc. The recall involves the ALTERA Spacer, 10x36, 9-13mm, 15¿, with Part # 1124.1232.
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. The affected lots include BAX103UE, BAX138JE, BAX167VE, BAX167UE, BAX227JE, and BAX413ME. The product was distributed worldwide.
Healthcare providers and patients should contact Globus Medical, Inc. for further instructions regarding the replacement or removal of these devices. No specific instructions for immediate consumer action are provided in the source text beyond the recall notification.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
- Manufacturer
- Globus Medical, Inc.
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 (7)
- Part #: 1124.1232
- Lot # / UDI #: BAX103UE / (01)00889095069945(10)BAX103UE
- BAX138JE / (01)00889095069945(10)BAX138JE
- BAX167VE / (01)00889095069945(10)BAX167VE
- BAX167UE / (01)00889095069945(10)BAX167UE
- BAX227JE / (01)00889095069945(10)BAX227JE
- BAX413ME / (01)00889095069945(10)BAX413ME
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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