ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
Check against the official notice below — it lists the full affected range.
Globus Medical, Inc. is recalling specific lots of ALTERA Spacer implants (part #1124.1211) used in spinal procedures. The recalled lots may contain internal components manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots have the following UDI numbers: BAX103VE, BAX109ME, BAX203PE, BAX315BE, BAX359ME, and BAX412WE. The implants were distributed worldwide.
The use of an incorrect material in the internal components could potentially affect the performance and durability of the implant. According to the source document, no remedy information is specified for 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 #: 1124.1211; Lot # / UDI #: BAX103VE / (01)00889095069877(10)BAX103VE; BAX109ME / (01)00889095069877(10)BAX109ME; BAX203PE / (01)00889095069877(10)BAX203PE; BAX315BE / (01)00889095069877(10)BAX315BE; BAX359ME / (01)00889095069877(10)BAX359ME; BAX412WE / (01)00889095069877(10)BAX412WE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.