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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
See all 22 products in this recall →Related recalls
Same manufacturer · Globus Medical, Inc.
See all →- HighGlobus Medical MAGEC 2 Rod recalled for incorrect outer diameter assembly
FDA (Devices) · 2025-04-30
- HighGlobus Medical Cranial Drills recalled for sterility loss and discoloration
FDA (Devices) · 2024-02-14
- HighGlobus Medical Cannula May Not Be Properly Sterilized
FDA (Devices) · 2024-02-14
- HighGlobus Medical Cranial Drill recalled for sterility breach risk
FDA (Devices) · 2024-02-14
- HighGlobus Medical Cranial Drill recalled for potential sterility compromise
FDA (Devices) · 2024-02-14
Same hazard · material defect
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- HighNexxZr dental zirconia discs may have reduced or missing dentin layer
FDA (Devices) · 2026-06-17
Similar recalls
- ModerateIntegra Recalls Salto Talaris Ankle Prosthesis Due to Labeling Error
FDA (Devices) · 2019-04-24
- ModerateIntegra Talar Dome Ankle Prosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2019-04-24
- ModerateIntegra Talar Dome Total Ankle Prosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2019-04-24
- ModerateIntegra Salto Talaris Ankle Prosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2019-04-24
- ModerateIntegra Talar Dome Total Ankle Prosthesis Recalled for Labeling Error
FDA (Devices) · 2019-04-24
- ModerateIntegra LifeSciences Recalls Talar Dome Ankle Prostheses Due to Labeling Error
FDA (Devices) · 2019-04-24