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 manufactured using 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural or material defects in medical devices that could impact patient safety.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for specific lots of ALTERA Spacer implants manufactured by Globus Medical, Inc. The recall involves the ALTERA Spacer, 10x31, 8-12mm, 8° (sterile), identified by Part # 1124.1111S and Lot#/UDI # GBX132UC.
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. Patients who have received these specific implants should contact their healthcare provider for further evaluation and guidance regarding the potential impact of the material discrepancy.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
- 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 (2)
- Part #: 1124.1111S
- Lot#/UDI #: GBX132UC / (01)00889095720723(17)250511(10)GBX132UC
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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