ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
Check against the official notice below — it lists the full affected range.
Globus Medical, Inc. is recalling specific lots of ALTERA Spacer implants (10x36, 9-13mm, 8") due to a manufacturing defect. Internal components in certain lots may have been made from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots are identified by part number 1124.1212 and specific lot/UDI numbers: BAX103XE, BAX109NE, BAX250HE, BAX250FE, BAX256CE, and BAX257UE. These implants were distributed worldwide.
The source document does not specify a remedy or instructions 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 #: 1124.1212; Lot # / UDI #: BAX103XE / (01)00889095069884(10)BAX103XE; BAX109NE / (01)00889095069884(10)BAX109NE; BAX250HE / (01)00889095069884(10)BAX250HE; BAX250FE / (01)00889095069884(10)BAX250FE; BAX256CE / (01)00889095069884(10)BAX256CE; BAX257UE / (01)00889095069884(10)BAX257UE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.