STERIS Fine Traction Device — Class II medical device recall Z-1786-2013
Terminated recall by Steris Corporation, reported 2013-07-31, distributed nationwide. A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliabi
| Recall number | Z-1786-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2013-05-20 |
| Classified | 2013-07-22 |
| Reported by FDA | 2013-07-31 |
| Terminated | 2013-08-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 16 units |
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1786-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.