Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 adjustments to traction and orientation of the leg during orthopedic procedures.

U.S. FDA — Device Enforcement · United States · 2013-05-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1786-2013
Date of alert: 2013-05-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Steris Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0404913150

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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 adjustments to traction and orientation of the leg during orthopedic procedures.

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