Recall Z-3211-2017— Deerfield Imaging

Name: FDA recall Z-3211-2017
Creator: U.S. Food and Drug Administration
Published: 2017-08-14

Class II · Terminated

Class II FDA medical device recall by Deerfield Imaging, initiated 2017-08-14, terminated 2018-05-29. It names one FDA 510(k) clearance: K103493. Product: IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw. Reason: incorrect thread on thumbscrews.

Recalling firm: Deerfield Imaging
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Terminated: 2018-05-29
Firm location: Minnetonka, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K103493 — HEAD FIATION DEVICE (HFD 100)Imris, Inc.·cleared 2011-03-11

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

IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

Reason for recall

incorrect thread on thumbscrews

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