ALTERA Spacer ALTERA Spacer, 10x31, 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 (model 10x31, 10-14mm, 8°) that were distributed worldwide. The recalled implants contain internal components that may have been made from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lot numbers are BAX178LE, BAX178KE, BAX189PE, and BAX348EE (Part #1124.1113).
The use of incorrect material in these implants could potentially affect their performance or safety. The recall notice does not specify a remedy or what affected consumers should do.
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 #: 1124.1113; Lot # / UDI #: BAX178LE / (01)00889095069693(10)BAX178LE; BAX178KE / (01)00889095069693(10)BAX178KE; BAX189PE / (01)00889095069693(10)BAX189PE; BAX348EE / (01)00889095069693(10)BAX348EE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.