Z-1438-04

Optima Spinal System and Spinal Hook System, set screw component

Name: Z-1438-04 Optima Spinal System and Spinal Hook System, set screw component
Creator: U&I America
Published: 2004-08-10
License: https://open.fda.gov/license/

U&I America / initiated 2004-08-10 / Terminated

FDA source

U&I America began a recall of Optima Spinal System and Spinal Hook System, set screw component on 2004-08-10. The reason FDA records is "Threads on a set screw, as a component of a spinal fixation system, may break off during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1438-04
Status: Terminated
Initiated: 2004-08-10
Posted: 2004-09-08
Terminated: 2005-11-29
Recalling firm: U&I America
Product: Optima Spinal System and Spinal Hook System, set screw component.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: Threads on a set screw, as a component of a spinal fixation system, may break off during use.
FDA root cause: Other
Action: Consignee was notified by letter on 08/10/2004.
Quantity in commerce: 200 set screws
Distribution: CA
Product codes and lots: Part number SP3020 (revision 6), Lot # 04D033.

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)