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 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 is classified as FDA Class II and involves a material deviation in a medical implant. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
Globus Medical, Inc. is recalling specific lots of ALTERA Spacers. The recall involves the ALTERA Spacer, 10x36, 12-16mm, 15 degrees, with Part # 1124.1235. The affected units were distributed worldwide.
The recall was initiated because internal components of the implants may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. The specific lots affected are identified by UDI # BAX103WE and BAX227VE.
This is a Class II recall. The source text does not report any illnesses, injuries, or deaths associated with these specific lots. Healthcare providers and patients should verify their implant lot numbers against the provided UDI codes to determine if they are affected.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 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 (3)
- Part #: 1124.1235
- Lot # / UDI #: BAX103WE / (01)00889095069976(10)BAX103WE
- BAX227VE / (01)00889095069976(10)BAX227VE
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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