Globus Medical, Inc.: ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿

Is my product affected?

ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿

• UPC 00889095069549

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, 9-13mm, 15°) distributed worldwide. The recall was issued because internal components in certain lots may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots are identified by their UDI numbers: BAX095XE, BAX175CE, BAX185BE, and BAX299LE.

The source document does not specify what actions affected consumers should take in response to this recall.

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 #: 1124.1032; Lot # / UDI #: BAX095XE / (01)00889095069549(10)BAX095XE; BAX175CE / (01)00889095069549(10)BAX175CE; BAX185BE / (01)00889095069549(10)BAX185BE; BAX299LE / (01)00889095069549(10)BAX299LE

Source

Official record: FDA (Device enforcement) ↗

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

Related recalls

• ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿2020-07-22
• ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 15¿2020-07-22

All FDA (Device enforcement) recalls