ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 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 #1124.1132) due to a manufacturing defect affecting internal components. The implants in certain lots may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy, which is the material required for proper performance. The recalled lots are identified by their UDI numbers: BAX138HE, BAX177XE, BAX185CE, BAX195EE, BAX208NE, BAX299PE, BAX315CE, and BAX348BE. These implants were distributed worldwide.
The source document does not specify a remedy or recommended action 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 #: 1124.1132; Lot# / UDI #: BAX138HE / (01)00889095069747(10)BAX138HE; BAX177XE / (01)00889095069747(10)BAX177XE; BAX185CE / (01)00889095069747(10)BAX185CE; BAX195EE / (01)00889095069747(10)BAX195EE; BAX208NE / (01)00889095069747(10)BAX208NE; BAX299PE / (01)00889095069747(10)BAX299PE; BAX315CE / (01)00889095069747(10)BAX315CE; BAX348BE / (01)00889095069747(10)BAX348BE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.