Recall Z-1657-2025— Globus Medical, Inc.

Name: FDA recall Z-1657-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-03

Class II · Ongoing

Class II FDA medical device recall by Globus Medical, Inc., initiated 2025-04-03. It names one FDA 510(k) clearance: K171791. Product: MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;. Reason: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm..

Recalling firm: Globus Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-03
Firm location: West Norriton, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K171791 — MAGEC® SystemNuvasive Specialized Orthopedics, Incorporated·cleared 2017-08-31

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

MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;

Reason for recall

Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.

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