—#195987

Product

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

FDA product code: GDZ — Handle, Scalpel
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621

Why it was recalled

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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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

Timeline

Recall initiated: 2022-09-02
Posted by FDA: 2022-10-12
Terminated: 2025-01-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.