Device product

ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿

Z-2862-2020

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-2862-2020

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 #: 1124.1132; Lot# / UDI #: BAX138HE / (01)00889095069747(10)BAX138HE; BAX177XE / (01)00889095069747(10)BAX177XE; BAX185CE / (01)00889095069747(10)BAX185CE; BAX195EE / (01)00889095069747(10)BAX195EE; BAX208NE / (01)00889095069747(10)BAX208NE; BAX299PE / (01)00889095069747(10)BAX299PE; BAX315CE / (01)00889095069747(10)BAX315CE; BAX348BE / (01)00889095069747(10)BAX348BE

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.