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.
What this means for you
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 defect (stainless steel instead of cobalt chromium molybdenum) which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x26, 12-16mm, 15° model.
The recall was initiated because internal components of these specific implants may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. The affected lots are identified by the following UDI/Lot numbers: BAX112UE, BAX212UE, BAX219JE, BAX348AE, BAX367GE, and BAX431UE. The product was distributed worldwide.
The source text does not specify the number of units affected or report any illnesses or injuries. Consumers and healthcare providers should verify the lot numbers of their devices against the list provided in the recall notice.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
- 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 (7)
- Part #: 1124.1035
- Lot # / UDI #: BAX112UE / (01)00889095069570(10)BAX112UE
- BAX212UE / (01)00889095069570(10)BAX212UE
- BAX219JE / (01)00889095069570(10)BAX219JE
- BAX348AE / (01)00889095069570(10)BAX348AE
- BAX367GE / (01)00889095069570(10)BAX367GE
- BAX431UE / (01)00889095069570(10)BAX431UE
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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