Recall Z-1941-2020— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-1941-2020
Creator: U.S. Food and Drug Administration
Published: 2020-03-26

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2020-03-26, terminated 2021-03-26. It names one FDA 510(k) clearance: K081297. Product: VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628. Reason: Nonconforming product; length of the product measured shorter than the labeled length..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Terminated
Initiated: 2020-03-26
Terminated: 2021-03-26
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K081297 — VERTEX RECONSTRUCTION SYSTEMMedtronic Sofamor Danek·cleared 2008-06-11

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

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Reason for recall

Nonconforming product; length of the product measured shorter than the labeled length.

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