Severity
Moderate
FDA Devices recall · Reported July 31, 2013
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 wa…
Steris Corporation recalled STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device… - a moderate-severity action.
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device… was recalled by Steris Corporation in July 31, 2013. Reason: A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliab…. Check the official notice for the remedy. Verify recall #Z-1786-2013 with the FDA Devices before acting.
The recall
Steris Corporation issued this moderate-severity FDA Devices recall-A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliab….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1786-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1786-2013) was formally reported on July 31, 2013, with the manufacturer initiating the action on May 20, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Steris Corporation is listed as the recalling firm, operating out of Mentor, OH. Federal records list the affected scope as 16 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
16 units
Related Recalls
6
3 from same agency
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.
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1786-2013 |
| Date reported | July 31, 2013 |
| Date initiated | May 20, 2013 |
| Recalling firm | Steris Corporation |
| Firm location | Mentor, OH |
| Affected scope | 16 units |
| Distribution | USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 31, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.