Globus Medical Recalls ALTERA Spacers Due to Incorrect Material Composition
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may be made of stainless steel instead of the specified cobalt chromium molybdenum alloy.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source identifies this as an FDA Class II recall. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving significant material deviations in implanted medical devices.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers, a medical device used for spinal procedures. The recall involves the ALTERA Spacer, 10x26, 10-14mm, 15° model.
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 intended material specification is the basis for the corrective action.
The affected products were distributed worldwide. The recall includes specific part and lot numbers, such as Part # 1124.1033 and various UDI codes starting with BAX. Healthcare providers and patients who have received these specific implants should contact Globus Medical or their healthcare provider for further instructions.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
- Manufacturer
- Globus Medical, Inc.
- Category
- Medical Device — Spinal Implant
- 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 (10)
- Part #: 1124.1033
- Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE
- BAX126AE / (01)00889095069556(10)BAX126AE
- BAX126WE / (01)00889095069556(10)BAX126WE
- BAX207AE / (01)00889095069556(10)BAX207AE
- BAX244KE / (01)00889095069556(10)BAX244KE
- BAX264UE / (01)00889095069556(10)BAX264UE
- BAX256DE / (01)00889095069556(10)BAX256DE
- BAX348DE / (01)00889095069556(10)BAX348DE
- BAX351NE / (01)00889095069556(10)BAX351NE
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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