The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2851-2020·Announced 2020-09-02

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.

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 is classified as FDA Class II, which indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The hazard involves a material substitution in a medical implant, which poses a risk of harm, but the source text does not report specific injuries or illnesses.

Plain-English summary

Globus Medical, Inc. is recalling specific lots of ALTERA Spacers (Part # 1124.1011). The recall involves devices with internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

The affected products were distributed worldwide. Specific lot numbers and UDI codes are listed in the agency's recall record, including BAX112RE, BAX125YE, and BAX134BE, among others.

Consumers and healthcare providers should check their inventory for the specific lot numbers and UDI codes listed in the official recall notice. If the product matches the recalled lots, it should be removed from use and returned to the manufacturer or distributor according to the instructions provided by Globus Medical.

The recalled product

Product
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Manufacturer
Globus Medical, Inc.
Category
Medical Device — Orthopedic Implants
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 (18)

  • Part #: 1124.1011
  • Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE
  • BAX125YE / (01)00889095258356(10)BAX125YE
  • BAX134BE / (01)00889095258356(10)BAX134BE
  • BAX095YE / (01)00889095258356(10)BAX095YE
  • BAX177TE / (01)00889095258356(10)BAX177TE
  • BAX177RE / (01)00889095258356(10)BAX177RE
  • BAX185AE / (01)00889095258356(10)BAX185AE
  • BAX096AE / (01)00889095258356(10)BAX096AE
  • BAX167ME / (01)00889095258356(10)BAX167ME
  • BAX195UE / (01)00889095258356(10)BAX195UE
  • BAX209SE / (01)00889095258356(10)BAX209SE
  • BAX209TE / (01)00889095258356(10)BAX209TE
  • BAX244HE / (01)00889095258356(10)BAX244HE
  • BAX250DE / (01)00889095258356(10)BAX250DE
  • BAX299JE / (01)00889095258356(10)BAX299JE
  • BAX398VE / (01)00889095258356(10)BAX398VE
  • BAX431TE / (01)00889095258356(10)BAX156LE

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 →

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