medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x36, 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 #: 1124.1213; Lot # / UDI #: BAX128PE / (01)00889095069891(10)BAX128PE; BAX207CE / (01)00889095069891(10)BAX207CE; BAX128NE / (01)00889095069891(10)BAX128NE; BAX250EE / (01)00889095069891(10)BAX250EE; BAX256BE / (01)00889095069891(10)BAX256BE
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