Skip to content
Recall Observatory FDA recall evidence

Device product

Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

Z-0079-2023

September 02, 2022

Class II

Product summary

Firm
Steris Corporation
Event
Event 90837
Status
Terminated
Classification
Class II
Quantity
5 US; 62 OUS
Official record key
device-enforcement:Z-0079-2023

Official wording

Reason: The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.

Code information: UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621

Distribution pattern: Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.