Globus Medical, Inc.: ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

Is my product affected?

ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿

• UPC 00889095258356

Check against the official notice below — it lists the full affected range.

What happened

Globus Medical, Inc. is recalling specific lots of ALTERA Spacer implants (10x26, 8-12mm) because internal components in these units may have been manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected implants have been distributed worldwide and are identified by part number 1124.1011, with multiple lot numbers listed including BAX112RE, BAX125YE, BAX134BE, BAX095YE, BAX177TE, BAX177RE, BAX185AE, BAX096AE, BAX167ME, BAX195UE, BAX209SE, BAX209TE, BAX244HE, BAX250DE, BAX299JE, BAX398VE, and BAX431TE.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

Details from the source

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 #: 1124.1011; Lot #/ UDI #: BAX112RE / (01)00889095258356(10)BAX112RE; BAX125YE / (01)00889095258356(10)BAX125YE; BAX134BE / (01)00889095258356(10)BAX134BE; BAX095YE / (01)00889095258356(10)BAX095YE; BAX177TE / (01)00889095258356(10)BAX177TE; BAX177RE / (01)00889095258356(10)BAX177RE; BAX185AE / (01)00889095258356(10)BAX185AE; BAX096AE / (01)00889095258356(10)BAX096AE; BAX167ME / (01)00889095258356(10)BAX167ME; BAX195UE / (01)00889095258356(10)BAX195UE; BAX209SE / (01)00889095258356(10)BAX209SE; BAX209TE / (01)00889095258356(10)BAX209TE; BAX244HE / (01)00889095258356(10)BAX244HE; BAX250DE / (01)00889095258356(10)BAX250DE; BAX299JE / (01)00889095258356(10)BAX299JE; BAX398VE / (01)00889095258356(10)BAX398VE; BAX431TE / (01)00889095258356(10)BAX156LE

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿2020-07-22

All FDA (Device enforcement) recalls