FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect
Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with 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 (incorrect alloy) which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers (Part #: 1124.1132). The recall involves the 10x31, 9-13mm, 15-degree model. The affected lots were distributed worldwide.
The recall is being issued because internal components of these specific implants may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare providers and patients should check their inventory and patient records for the specific lot numbers listed in the recall notice. If a patient has received an affected implant, they should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
- Manufacturer
- Globus Medical, Inc.
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 (9)
- Part #: 1124.1132
- Lot# / UDI #: BAX138HE / (01)00889095069747(10)BAX138HE
- BAX177XE / (01)00889095069747(10)BAX177XE
- BAX185CE / (01)00889095069747(10)BAX185CE
- BAX195EE / (01)00889095069747(10)BAX195EE
- BAX208NE / (01)00889095069747(10)BAX208NE
- BAX299PE / (01)00889095069747(10)BAX299PE
- BAX315CE / (01)00889095069747(10)BAX315CE
- BAX348BE / (01)00889095069747(10)BAX348BE
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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