Recall Z-1786-2013 ยท HST Apparatus, Traction, Non-Powered
Steris Corporation
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.
| Date | Jul 22, 2013 (initiated May 20, 2013) |
| Status | Terminated |
| 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 |
| 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 | 16 units |
| Distribution | USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.