FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error
Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been made of 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 involves a medical device with a material composition error (stainless steel instead of cobalt chromium molybdenum). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported in the source text, and it is not explicitly classified as FDA Class I or associated with reported hospitalizations.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacer implants. The recall is due to a manufacturing error where internal components may have been produced using stainless steel rather than the specified cobalt chromium molybdenum alloy.
The affected product is the ALTERA Spacer, 10x36, 12-16mm, 8¿. The specific part number is 1124.1215. The recall includes lots with UDI numbers BAX112XE and BAX250LE. The source text indicates that these products had worldwide distribution.
The source text does not provide specific instructions for consumers or patients on how to respond to this recall, nor does it report any specific injuries or illnesses associated with the material discrepancy. Patients with these implants should consult their healthcare providers for guidance.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 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 (3)
- Part #: 1124.1215
- Lot # / UDI #: BAX112XE / (01)00889095069914(10)BAX112XE
- BAX250LE / (01)00889095069914(10)BAX250LE
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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