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
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving structural or material defects in medical devices.
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x31, 8-12mm, 8¿ model. The affected products were distributed worldwide.
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. The recall covers specific part and lot numbers, including Part # 1124.1111 and various UDI codes such as BAX156ME, BAX156NE, BAX167PE, BAX229VE, BAX290TE, BAX290UE, BAX294WE, BAX376DE, and BAX376CE.
This recall is classified as Class II by the U.S. Food and Drug Administration. Patients who have received these specific implants should contact their healthcare provider for further instructions.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 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 (10)
- Part #: 1124.1111
- Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME
- BAX156NE / (01)00889095069679(10)BAX156NE
- BAX167PE / (01)00889095069679(10)BAX167PE
- BAX229VE / (01)00889095069679(10)BAX229VE
- BAX290TE / (01)00889095069679(10)BAX290TE
- BAX290UE / (01)00889095069679(10)BAX290UE
- BAX294WE / (01)00889095069679(10)BAX294WE
- BAX376DE / (01)00889095069679(10)BAX376DE
- BAX376CE / (01)00889095069679(10)BAX376CE
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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