medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 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 #: 1124.1215; Lot # / UDI #: BAX112XE / (01)00889095069914(10)BAX112XE; BAX250LE / (01)00889095069914(10)BAX250LE
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