ALTERA Spacer ALTERA Spacer, 10x31, 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 (10x31, 8-12mm) because internal components in these units may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots were distributed worldwide and include nine specific lot numbers: BAX156ME, BAX156NE, BAX167PE, BAX229VE, BAX290TE, BAX290UE, BAX294WE, BAX376DE, and BAX376CE (Part #1124.1111).
The use of an unspecified material in place of the intended alloy could potentially affect the performance and safety of the implant. The source document does not specify a remedy or corrective action that affected consumers should take.
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 #: 1124.1111; Lot # / UDI #: BAX156ME / (01)00889095069679(10)BAX156ME; BAX156NE / (01)00889095069679(10)BAX156NE; BAX167PE / (01)00889095069679(10)BAX167PE; BAX229VE / (01)00889095069679(10)BAX229VE; BAX290TE / (01)00889095069679(10)BAX290TE; BAX290UE / (01)00889095069679(10)BAX290UE; BAX294WE / (01)00889095069679(10)BAX294WE; BAX376DE / (01)00889095069679(10)BAX376DE; BAX376CE / (01)00889095069679(10)BAX376CE
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.