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Recall Observatory FDA recall evidence

Device product

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿

Z-2866-2020

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-2866-2020

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 #: 1124.1212; Lot # / UDI #: BAX103XE / (01)00889095069884(10)BAX103XE; BAX109NE / (01)00889095069884(10)BAX109NE; BAX250HE / (01)00889095069884(10)BAX250HE; BAX250FE / (01)00889095069884(10)BAX250FE; BAX256CE / (01)00889095069884(10)BAX256CE; BAX257UE / (01)00889095069884(10)BAX257UE

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.