ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿
Check against the official notice below — it lists the full affected range.
Globus Medical, Inc. is recalling specific lots of ALTERA Spacer implants (Part #1124.1033) used in spinal surgery. The recalled lots may contain internal components manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lot numbers are BAX112VE, BAX126AE, BAX126WE, BAX207AE, BAX244KE, BAX264UE, BAX256DE, BAX348DE, and BAX351NE, and these products were distributed worldwide.
The use of incorrect material in these implants could potentially affect their performance or biocompatibility. The recall notice does not specify a remedy or instructions 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 #: 1124.1033; Lot # / UDI #: BAX112VE / (01)00889095069556(10)BAX112VE; BAX126AE / (01)00889095069556(10)BAX126AE; BAX126WE / (01)00889095069556(10)BAX126WE; BAX207AE / (01)00889095069556(10)BAX207AE; BAX244KE / (01)00889095069556(10)BAX244KE; BAX264UE / (01)00889095069556(10)BAX264UE; BAX256DE / (01)00889095069556(10)BAX256DE; BAX348DE / (01)00889095069556(10)BAX348DE; BAX351NE / (01)00889095069556(10)BAX351NE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.