FDA Device recall Z-1786-2013
STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustmen…
- FDA Device
- Class II
- terminated
- Published 2013-07-31
On 2013-07-31 the FDA classified a Class II recall of STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustmen… by Steris, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1786-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-05-20 |
| Published | 2013-07-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Steris |
| Distribution | US |
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
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
Identifiers
| code_info | The following serial/lot numbers are affected by this recall: 0404913150, 0404913151, 0404913152, 0404913153, 040871…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1786-2013%22
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