Z-0558-04

2.5mm Hex Driver

Name: Z-0558-04 2.5mm Hex Driver
Creator: U&I America
Published: 2004-01-14
License: https://open.fda.gov/license/

U&I America / initiated 2004-01-14 / Terminated

FDA source

U&I America began a recall of 2.5mm Hex Driver on 2004-01-14. The reason FDA records is "Reports of hex driver tips breaking off or becoming worn or stripped". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0558-04
Status: Terminated
Initiated: 2004-01-14
Posted: 2004-02-27
Terminated: 2004-03-24
Recalling firm: U&I America
Product: 2.5mm Hex Driver
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Reports of hex driver tips breaking off or becoming worn or stripped.
FDA root cause: Other
Action: The only consignee was notified by letter on 1/14/2003.
Quantity in commerce: 320 units
Distribution: MN
Product codes and lots: Catalog Number OP20004, Lot #04160301 Catalog Number SP00005-US, Lot # O2F108, O2F109, O2G322, O2G323, O2G324, O3E221.

Product code MNI

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)