Z-0008-04

Rultract Surgical Retractor, 4100 Series, all system configurations, reusable

Name: Z-0008-04 Rultract Surgical Retractor, 4100 Series, all system configurations, reusable
Creator: Rultract Inc
Published: 2003-09-18
License: https://open.fda.gov/license/

Rultract Inc / initiated 2003-09-18 / Terminated

FDA source

Rultract Inc began a recall of Rultract Surgical Retractor, 4100 Series, all system configurations, reusable on 2003-09-18. The reason FDA records is "Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0008-04
Status: Terminated
Initiated: 2003-09-18
Posted: 2003-10-15
Terminated: 2007-03-23
Recalling firm: Rultract Inc
Product: Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Product code: DWS Instruments, Surgical, Cardiovascular
Reason for recall: Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.
FDA root cause: Other
Action: The firm notified their affected consignees by letter on 9/18/2003.
Quantity in commerce: 2,718 units
Distribution: The device was distributed to end-users located nationwide.
Product codes and lots: S/Ns: 0001 to 2005, and S/Ns: 2172 to 2885

Product code DWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)