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 involves a medical device with a material composition defect (stainless steel instead of cobalt chromium molybdenum). Per the rubric, this is classified as a risk-of-harm product where injury has not yet been reported, warranting a score of 3 (High).
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x31, 10-14mm, 8¿, with Part Number 1124.1113. The affected lots are BAX178LE, BAX178KE, BAX189PE, and BAX348EE.
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 affected products were distributed worldwide. The source text does not specify the number of units recalled or report any illnesses or injuries associated with the use of these devices. Consumers and healthcare providers should verify their inventory against the listed lot numbers and contact Globus Medical for further instructions.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
- 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 #: 1124.1113
- Lot # / UDI #: BAX178LE / (01)00889095069693(10)BAX178LE
- BAX178KE / (01)00889095069693(10)BAX178KE
- BAX189PE / (01)00889095069693(10)BAX189PE
- BAX348EE / (01)00889095069693(10)BAX348EE
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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