Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
FDA device recall Z-0079-2023 · posted 2022-10-12 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- GDZ
- Quantity affected
- 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.
- Date initiated
- 2022-09-02
- Date posted
- 2022-10-12
- Date terminated
- 2025-01-02
- Location
- Mentor, OH
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