Device product

ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿

Z-2868-2020

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-2868-2020

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 #: 1124.1215; Lot # / UDI #: BAX112XE / (01)00889095069914(10)BAX112XE; BAX250LE / (01)00889095069914(10)BAX250LE

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.