Skip to content
Recall Observatory FDA recall evidence

Device product

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿

Z-2852-2020

July 22, 2020

Class II

Product summary

Firm
Globus Medical, Inc.
Event
Event 86164
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2852-2020

Official wording

Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information: Part #: 1124.1012; Lot # / UDI #: BAX096BE / (01)00889095258363(10)BAX096BE; BAX112TE / (01)00889095258363(10)BAX112TE; BAX112SE / (01)00889095258363(10)BAX112SE; BAX177UE / (01)00889095258363(10)BAX177UE; BAX195VE / (01)00889095258363(10)BAX195VE; BAX229TE / (01)00889095258363(10)BAX229TE; BAX279WE / (01)00889095258363(10)BAX279WE; BAX288HE / (01)00889095258363(10)BAX288HE; BAX299GE / (01)00889095258363(10)BAX299GE; BAX367FE / (01)00889095258363(10)BAX367FE

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.