Device product
ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
Z-2851-2020
Product summary
- Event
- Event 86164
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-2851-2020
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 #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE
Distribution pattern: Worldwide Distribution
Derived failure modes
-
Unknown
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.