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 is classified as FDA Class II. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls under the 'High' severity category, representing 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. The recall involves the ALTERA Spacer, 10x36, 10-14mm, 15¿. The affected products were distributed worldwide.
The recall is being issued because internal components of the implants may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. This deviation from the specified material composition is the reason for the recall.
The specific lots affected are identified by Part # 1124.1233. The affected Lot # /UDI # are BAX196AE / (01)00889095069952(10)BAX196AE and BAX196CE / (01)00889095069952(10)BAX196CE. Consumers and healthcare providers should check their records for these specific lot numbers to determine if they are affected.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 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 #: 1124.1233
- Lot # /UDI #: BAX196AE / (01)00889095069952(10)BAX196AE
- BAX196CE / (01)00889095069952(10)BAX196CE
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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