medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: 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
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