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 involves a medical device with a material composition error (stainless steel instead of cobalt chromium molybdenum). While the agency classification is Class II, the source text does not report hospitalizations or significant injuries, fitting the 'High' 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 involves the ALTERA Spacer, 10x36, 9-13mm, 8¿, with Part Number 1124.1212. The affected lots include BAX103XE, BAX109NE, BAX250HE, BAX250FE, BAX256CE, and BAX257UE.
The recall was initiated because internal components of these specific implants may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. This material deviation differs from the intended manufacturing specifications for the device.
The affected products were distributed worldwide. The source text does not provide specific details on the number of units affected or reported adverse events. Consumers and healthcare providers should verify their inventory against the listed lot numbers and contact the manufacturer for further instructions.
The recalled product
- Product
- ALTERA Spacer ALTERA Spacer, 10x36, 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 (7)
- Part #: 1124.1212
- Lot # / UDI #: BAX103XE / (01)00889095069884(10)BAX103XE
- BAX109NE / (01)00889095069884(10)BAX109NE
- BAX250HE / (01)00889095069884(10)BAX250HE
- BAX250FE / (01)00889095069884(10)BAX250FE
- BAX256CE / (01)00889095069884(10)BAX256CE
- BAX257UE / (01)00889095069884(10)BAX257UE
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 →- LowParagon 28 Recalls Custom Foot Implant Due to Material Defect
FDA (Devices) · 2026-08-26
- ModerateParagon 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
- HighMAC two-lumen central venous kits recalled over incorrectly manufactured adhesive
FDA (Devices) · 2026-04-29
- HighArrowg+ard Blue Plus four-lumen CVC kits recalled over adhesive manufacturing
FDA (Devices) · 2026-04-29