FDA Device recall Z-2852-2020
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
- FDA Device
- Class II
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class II recall of ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿ by Globus Medical, citing specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2852-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-22 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Globus Medical |
| Distribution | n/a |
Product
ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
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.
Identifiers
| code_info | Part #: 1124.1012; Lot # / UDI #: BAX096BE / (01)00889095258363(10)BAX096BE; BAX112TE / (01)00889095258363(10)BAX112TE;…Part #: 1124.1012; Lot # / UDI #: BAX096BE / (01)00889095258363(10)BAX096BE; BAX112TE / (01)00889095258363(10)BAX112TE; BAX112SE / (01)00889095258363(10)BAX112SE; BAX177UE / (01)00889095258363(10)BAX177UE; BAX195VE / (01)00889095258363(10)BAX195VE; BAX229TE / (01)00889095258363(10)BAX229TE; BAX279WE / (01)00889095258363(10)BAX279WE; BAX288HE / (01)00889095258363(10)BAX288HE; BAX299GE / (01)00889095258363(10)BAX299GE; BAX367FE / (01)00889095258363(10)BAX367FE |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2852-2020%22
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