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U.S. Department of Health and Human Services

Class 2 Device Recall K360 Scalpel Handle

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  Class 2 Device Recall K360 Scalpel Handle see related information
Date Initiated by Firm September 02, 2022
Date Posted October 12, 2022
Recall Status1 Open3, Classified
Recall Number Z-0079-2023
Recall Event ID 90837
Product Classification Handle, scalpel - Product Code GDZ
Product Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Code Information UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Michelle LaVan
440-392-8603
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process design
Action Starting September 2, 2022, Hu-Friedy notified all affected customers and distributors via Urgent Medical Device Recall letters. Customers were instructed to immediately destroy all on-hand inventory of the affected lots of K360 Scalpel Handles. Distributors should identify and notify any of their customers who have received further distributed product. Hu-Friedy will issue credit upon receipt of completed response forms.
Quantity in Commerce 5 US; 62 OUS
Distribution Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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