Globus Medical Recalls ALTERA Spacers with Incorrect Stainless Steel Components
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 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 involving significant injury or structural defects are rated as Severe (4).
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x26, 12-16mm, 8¿ model.
The recall is being issued because internal components of these 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 reason for the recall.
The affected products were distributed worldwide. Specific lot numbers and UDI codes are listed in the recall documentation. Healthcare providers and patients should contact Globus Medical for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x26, 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 (5)
- Part #: 1124.1015
- Lot # / UDI #: BAX156KE / (01)00889095069518(10)BAX156KE
- BAX156LE / (01)00889095069518(10)BAX156LE
- BAX308CE / (01)00889095069518(10)BAX308CE
- BAX308DE / (01)00889095069518(10)BAX308DE
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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