Z-3211-2017Class II

IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw

Name: Z-3211-2017 IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Creator: Deerfield Imaging
Published: 2017-08-14
License: https://open.fda.gov/license/

IMRIS Imaging, Inc. / initiated 2017-08-14 / Terminated / root cause: manufacturing process

FDA source

Deerfield Imaging began a recall of IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw on 2017-08-14. FDA classified it as Class II and gives the reason as "incorrect thread on thumbscrews". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3211-2017
Classification: Class II
Status: Terminated
Initiated: 2017-08-14
Posted: 2017-09-22
Terminated: 2018-05-29
Recalling firm: IMRIS Imaging, Inc.
Product: IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Product code: HBL Holder, Head, Neurosurgical (Skull Clamp)
Reason for recall: incorrect thread on thumbscrews
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm notified the consignees by email on 08/14/2017. The letter stated that the screws would be replaced.
Quantity in commerce: 6 screws
Distribution: IL, OR, PA
Product codes and lots: Serial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3211-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3211-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-22

Product code HBL

K103493Class IIHead Fiation Device (Hfd 100)Imris, Inc. / cleared 2011-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)