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Recall Observatory FDA recall evidence

Device product

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿

Z-2857-2020

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-2857-2020

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 #: 1124.1035; Lot # / UDI #: BAX112UE / (01)00889095069570(10)BAX112UE; BAX212UE / (01)00889095069570(10)BAX212UE; BAX219JE / (01)00889095069570(10)BAX219JE; BAX348AE / (01)00889095069570(10)BAX348AE; BAX367GE / (01)00889095069570(10)BAX367GE; BAX431UE / (01)00889095069570(10)BAX431UE

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.