ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
Check against the official notice below — it lists the full affected range.
Globus Medical is recalling specific lots of ALTERA Spacer implants (model 10x31, 12-16mm, 15°) because internal components in these units may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots have the following identifiers: Part #1124.1135 with lot/UDI numbers BAX178PE, BAX236NE, BAX398UE, and BAX431SE. These implants were distributed worldwide.
The recall notice does not specify a remedy or recommended 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 #: 1124.1135; Lot # / UDI #: BAX178PE / (01)00889095069778(10)BAX178PE; BAX236NE / (01)00889095069778(10)BAX236NE; BAX398UE / (01)00889095069778(10)BAX398UE; BAX431SE / (01)00889095069778(10)BAX431SE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.