medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

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 #: 1124.1232; Lot # / UDI #: BAX103UE / (01)00889095069945(10)BAX103UE; BAX138JE / (01)00889095069945(10)BAX138JE; BAX167VE / (01)00889095069945(10)BAX167VE; BAX167UE / (01)00889095069945(10)BAX167UE; BAX227JE / (01)00889095069945(10)BAX227JE; BAX413ME / (01)00889095069945(10)BAX413ME
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