Device product

ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿

Z-2869-2020

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-2869-2020

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 #: 1124.1232; Lot # / UDI #: BAX103UE / (01)00889095069945(10)BAX103UE; BAX138JE / (01)00889095069945(10)BAX138JE; BAX167VE / (01)00889095069945(10)BAX167VE; BAX167UE / (01)00889095069945(10)BAX167UE; BAX227JE / (01)00889095069945(10)BAX227JE; BAX413ME / (01)00889095069945(10)BAX413ME

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.