medical Class II Updated 2020-09-02

Globus Medical, Inc. recalls ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿

Recalled Product

ALTERA Spacer ALTERA Spacer, 10x26, 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 #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE
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