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 made with stainless steel instead of the specified cobalt chromium molybdenum alloy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 substitution in a medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, aligning with the 'High' severity criteria 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 (10x36, 8-12mm, 8°). The recall is due to a manufacturing defect where internal components may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
The affected products were distributed worldwide. The specific lots involved are identified by the following UDI/Lot numbers: BAX103VE, BAX109ME, BAX203PE, BAX315BE, BAX359ME, and BAX412WE, all associated with Part # 1124.1211.
Healthcare providers and patients should check their records to determine if they have received or used these specific lots. If a patient has an affected implant, they should contact their healthcare provider for further evaluation and guidance.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
- 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 #: 1124.1211
- Lot # / UDI #: BAX103VE / (01)00889095069877(10)BAX103VE
- BAX109ME / (01)00889095069877(10)BAX109ME
- BAX203PE / (01)00889095069877(10)BAX203PE
- BAX315BE / (01)00889095069877(10)BAX315BE
- BAX359ME / (01)00889095069877(10)BAX359ME
- BAX412WE / (01)00889095069877(10)BAX412WE
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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