medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 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 #: 1124.1133; Lot # / UDI #: BAX108TE / (01)00889095069754(10)BAX108TE; BAX178ME / (01)00889095069754(10)BAX178ME; BAX208TE / (01)00889095069754(10)BAX208TE; BAX299NE / (01)00889095069754(10)BAX299NE; BAX413CE / (01)00889095069754(10)BAX413CE; BAX413GE / (01)00889095069754(10)BAX413GE
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