Device product

ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿

Z-2864-2020

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-2864-2020

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 #: 1124.1135; Lot # / UDI #: BAX178PE / (01)00889095069778(10)BAX178PE; BAX236NE / (01)00889095069778(10)BAX236NE; BAX398UE / (01)00889095069778(10)BAX398UE; BAX431SE / (01)00889095069778(10)BAX431SE

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.