PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported July 31, 2013

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 wa…

Recall #
Z-1786-2013
Affected scope
16 units
Initiated
May 20, 2013
Compiled from official public sources by the editorial team.
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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….

Moderate
severity level
16 units
affected scope
Class II
classification
July 31, 2013
reported

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.

Recall Insight

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.

Medical Devices recalls over time

Where this recall sits in its category - 40,322 medical devices recalls on record

-1,00001,0002,0003,0004,000 20052008201120142017202020232026 1,248
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

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

Product description

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.

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

Recall Profile

Structured summary of the FDA Devices recall record
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.

Scale of Impact

16 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-1786-2013) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

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.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Steris Corporation. Units affected: 16 units.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on July 31, 2013. Severity: Moderate. Recall number: Z-1786-2013.
Where was the recalled product distributed?
Distribution: USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1786-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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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.