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Recall Observatory FDA recall evidence

Device product

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

Z-2854-2020

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-2854-2020

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 #: 1124.1015; Lot # / UDI #: BAX156KE / (01)00889095069518(10)BAX156KE; BAX156LE / (01)00889095069518(10)BAX156LE; BAX308CE / (01)00889095069518(10)BAX308CE; BAX308DE / (01)00889095069518(10)BAX308DE

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.