ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
Check against the official notice below — it lists the full affected range.
Globus Medical is recalling specific lots of ALTERA Spacer implants (10x31, 12-16mm, 8mm) because internal components in these devices may have been manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lot numbers are BAX159RE, BAX178JE, BAX208RE, BAX229UE, BAX250BE, BAX308BE, BAX347YE, and BAX351KE, and these implants were distributed worldwide.
The recall notice does not specify a remedy or recommended action for affected consumers.
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 #: 1124.1115; Lot # / UDI #: BAX159RE / (01)00889095069716(10)BAX159RE; BAX178JE / (01)00889095069716(10)BAX178JE; BAX208RE / (01)00889095069716(10)BAX208RE; BAX229UE / (01)00889095069716(10)BAX229UE; BAX250BE / (01)00889095069716(10)BAX250BE; BAX308BE / (01)00889095069716(10)BAX308BE; BAX347YE / (01)00889095069716(10)BAX347YE; BAX351KE / (01)00889095069716(10)BAX351KE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.