medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 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 #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE
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