Globus Medical, Inc.: ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿

Is my product affected?

ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿

• UPC 00889095069891

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

What happened

Globus Medical is recalling specific lots of ALTERA Spacer implants (10x36, 10-14mm, 8") because internal components in these units may have been manufactured from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lots have been distributed worldwide and include five specific lot numbers: BAX128PE, BAX207CE, BAX128NE, BAX250EE, and BAX256BE.

The recall notice 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.

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 #: 1124.1213; Lot # / UDI #: BAX128PE / (01)00889095069891(10)BAX128PE; BAX207CE / (01)00889095069891(10)BAX207CE; BAX128NE / (01)00889095069891(10)BAX128NE; BAX250EE / (01)00889095069891(10)BAX250EE; BAX256BE / (01)00889095069891(10)BAX256BE

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, 9-13mm, 15¿2020-07-22

All FDA (Device enforcement) recalls