ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
Check against the official notice below — it lists the full affected range.
Globus Medical is recalling specific lots of ALTERA Spacer implants (Part #1124.1013) because internal components in these devices may have been manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots are identified by UDI numbers BAX104GE, BAX156GE, BAX156HE, BAX195WE, and BAX361LE, and these implants have been distributed worldwide.
The source document does not specify what action affected consumers or patients should take in response to this recall.
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 #: 1124.1013; Lot # / UDI #: BAX104GE / (01)00889095069495(10)BAX104GE; BAX156GE / (01)00889095069495(10)BAX156GE; BAX156HE / (01)00889095069495(10)BAX156HE; BAX195WE / (01)00889095069495(10)BAX195WE; BAX361LE / (01)00889095069495(10)BAX361LE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.