Recall Z-2857-2020— Globus Medical, Inc.

Name: FDA recall Z-2857-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-22

Class II · Terminated

Class II FDA medical device recall by Globus Medical, Inc., initiated 2020-07-22, terminated 2021-08-19. It names one FDA 510(k) clearance: K140411. Product: ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿. Reason: Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy..

Recalling firm: Globus Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-22
Terminated: 2021-08-19
Firm location: Audubon, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K140411 — ALTERA SPACERGlobus Medical, Inc.·cleared 2014-07-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.