Device product
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192
Z-1289-2024
Product summary
- Event
- Event 94037
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14 units
- Official record key
device-enforcement:Z-1289-2024
Official wording
Reason: Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.
Code information: UDI/DI 00615521000851, Lot Numbers: 23-140, 23-268, 23-314
Distribution pattern: US Nationwide distribution in the state of Alabama.
Derived failure modes
-
Unknown
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot to detach from the traction system. If an impacted device is used during surgery, the boot may detach from the traction system, potentially leading to patient harm and a delay in surgery.