ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
Check against the official notice below — it lists the full affected range.
Globus Medical, Inc. is recalling specific lots of ALTERA Spacer implants (10x26, 12-16mm, 15°) because internal components in these devices may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots are identified by part number 1124.1035 with six specific lot numbers: BAX112UE, BAX212UE, BAX219JE, BAX348AE, BAX367GE, and BAX431UE. These implants have been distributed worldwide.
The recall notice does not specify a remedy or recommended course of action for consumers who may 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 #: 1124.1035; Lot # / UDI #: BAX112UE / (01)00889095069570(10)BAX112UE; BAX212UE / (01)00889095069570(10)BAX212UE; BAX219JE / (01)00889095069570(10)BAX219JE; BAX348AE / (01)00889095069570(10)BAX348AE; BAX367GE / (01)00889095069570(10)BAX367GE; BAX431UE / (01)00889095069570(10)BAX431UE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.