Z-1786-2013Class II

STERIS Fine Traction Device, one unit per box

Name: Z-1786-2013 STERIS Fine Traction Device, one unit per box
Creator: Steris Corporation
Published: 2013-05-20
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2013-05-20 / Terminated

FDA source

Steris Corporation began a recall of STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and... on 2013-05-20. FDA classified it as Class II and gives the reason as "A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1786-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-20
Posted: 2013-07-22
Terminated: 2013-08-28
Recalling firm: STERIS Corporation
Product: STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
Product code: HST Apparatus, Traction, Non-Powered
Reason for recall: A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati
FDA root cause: Component change control
Action: STERIS Account Managers notified affected customers via onsite visits. All consignees were notified as of 5/29/2013. Customers were instructed to return affected product for a replacement unit.
Quantity in commerce: 16 units
Distribution: USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
Product codes and lots: The following serial/lot numbers are affected by this recall: 0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1786-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1786-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-31	2013-07-22

Product code HST

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)