Device product

ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿

Z-2860-2020

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-2860-2020

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 #: 1124.1113; Lot # / UDI #: BAX178LE / (01)00889095069693(10)BAX178LE; BAX178KE / (01)00889095069693(10)BAX178KE; BAX189PE / (01)00889095069693(10)BAX189PE; BAX348EE / (01)00889095069693(10)BAX348EE

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.