Globus Medical Recalls Specific Lots of ALTERA Spacers
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 deviation (stainless steel instead of cobalt chromium molybdenum) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity 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 is due to a manufacturing issue where internal components of the implants may have been made using stainless steel rather than the specified cobalt chromium molybdenum alloy.
The affected products are distributed worldwide. The recall includes specific part numbers and lot numbers, including BAX137PE, BAX167SE, BAX178FE, BAX208LE, BAX250CE, BAX348CE, and BAX431NE.
Consumers and healthcare providers should check their records to determine if they possess the affected lots. If the product is identified, they should contact Globus Medical for instructions on how to proceed.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 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 (8)
- Part #: 1124.1112
- Lot # / UDI #: BAX137PE / (01)00889095069686(10)BAX137PE
- BAX167SE / (01)00889095069686(10)BAX167SE
- BAX178FE / (01)00889095069686(10)BAX178FE
- BAX208LE / (01)00889095069686(10)BAX208LE
- BAX250CE / (01)00889095069686(10)BAX250CE
- BAX348CE / (01)00889095069686(10)BAX348CE
- BAX431NE / (01)00889095069686(10)BAX431NE
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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