ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
Check against the official notice below — it lists the full affected range.
Globus Medical is recalling specific lots of ALTERA Spacer implants (10x26, 9-13mm, 8¿ model) because internal components in these units may have been manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected implants were distributed worldwide and include ten specific lot numbers: BAX096BE, BAX112TE, BAX112SE, BAX177UE, BAX195VE, BAX229TE, BAX279WE, BAX288HE, BAX299GE, and BAX367FE (all part number 1124.1012).
The recall record does not specify a remedy or corrective action for consumers who have received these implants.
Written by software from the official notice below. Not reviewed by a lawyer.
Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.
Reason for recall: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy. Distribution: Worldwide Distribution Quantity: N/A Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.