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.
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). While the agency classifies this as Class II, the source text does not report any illnesses, injuries, or hospitalizations. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x36, 10-14mm, 8¿ model. The affected units were distributed worldwide.
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 part number is 1124.1213. Specific lot numbers and UDI codes are listed in the source metadata, including BAX128PE, BAX207CE, BAX128NE, BAX250EE, and BAX256BE.
Healthcare providers and patients should check their records to determine if they have received the affected lots. If a patient has received an affected implant, they should contact their healthcare provider for further instructions.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 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 (6)
- Part #: 1124.1213
- Lot # / UDI #: BAX128PE / (01)00889095069891(10)BAX128PE
- BAX207CE / (01)00889095069891(10)BAX207CE
- BAX128NE / (01)00889095069891(10)BAX128NE
- BAX250EE / (01)00889095069891(10)BAX250EE
- BAX256BE / (01)00889095069891(10)BAX256BE
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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