medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 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 #: 1124.1211; Lot # / UDI #: BAX103VE / (01)00889095069877(10)BAX103VE; BAX109ME / (01)00889095069877(10)BAX109ME; BAX203PE / (01)00889095069877(10)BAX203PE; BAX315BE / (01)00889095069877(10)BAX315BE; BAX359ME / (01)00889095069877(10)BAX359ME; BAX412WE / (01)00889095069877(10)BAX412WE
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