ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
Check against the official notice below — it lists the full affected range.
Globus Medical is recalling specific lots of ALTERA Spacer implants (10x31, 9-13mm, 8 inch) because internal components in these units may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots are distributed worldwide and include part number 1124.1112 with multiple lot numbers: BAX137PE, BAX167SE, BAX178FE, BAX208LE, BAX250CE, BAX348CE, and BAX431NE.
The recall record 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 #: 1124.1112; Lot # / UDI #: BAX137PE / (01)00889095069686(10)BAX137PE; BAX167SE / (01)00889095069686(10)BAX167SE; BAX178FE / (01)00889095069686(10)BAX178FE; BAX208LE / (01)00889095069686(10)BAX208LE; BAX250CE / (01)00889095069686(10)BAX250CE; BAX348CE / (01)00889095069686(10)BAX348CE; BAX431NE / (01)00889095069686(10)BAX431NE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.