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Recall Observatory FDA recall evidence

Device product

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿

Z-2859-2020

July 22, 2020

Class II

Product summary

Firm
Globus Medical, Inc.
Event
Event 86164
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2859-2020

Official wording

Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Code information: Part #: 1124.1112; Lot # / UDI #: BAX137PE / (01)00889095069686(10)BAX137PE; BAX167SE / (01)00889095069686(10)BAX167SE; BAX178FE / (01)00889095069686(10)BAX178FE; BAX208LE / (01)00889095069686(10)BAX208LE; BAX250CE / (01)00889095069686(10)BAX250CE; BAX348CE / (01)00889095069686(10)BAX348CE; BAX431NE / (01)00889095069686(10)BAX431NE

Distribution pattern: Worldwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.