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Recall Observatory FDA recall evidence

Device product

ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿

Z-2858-2020

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-2858-2020

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 #: 1124.1111; Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME; BAX156NE / (01)00889095069679(10)BAX156NE; BAX167PE / (01)00889095069679(10)BAX167PE; BAX229VE / (01)00889095069679(10)BAX229VE; BAX290TE / (01)00889095069679(10)BAX290TE; BAX290UE / (01)00889095069679(10)BAX290UE; BAX294WE / (01)00889095069679(10)BAX294WE; BAX376DE / (01)00889095069679(10)BAX376DE; BAX376CE / (01)00889095069679(10)BAX376CE

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.