Globus Medical, Inc.: ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

Is my product affected?

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 8¿

• UPC 00889095069518

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

What happened

Globus Medical is recalling specific lots of ALTERA Spacer implants (8-inch model, 10x26mm, 12-16mm sizes) because internal components in certain units may have been made from stainless steel instead of the specified cobalt chromium molybdenum alloy. The affected lot numbers are BAX156KE, BAX156LE, BAX308CE, and BAX308DE. These implants have been distributed worldwide.

The recall notice does not specify a remedy for affected consumers or patients with these implants.

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 #: 1124.1015; Lot # / UDI #: BAX156KE / (01)00889095069518(10)BAX156KE; BAX156LE / (01)00889095069518(10)BAX156LE; BAX308CE / (01)00889095069518(10)BAX308CE; BAX308DE / (01)00889095069518(10)BAX308DE

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

All FDA (Device enforcement) recalls