Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps an

FDA device recall Z-0521-2025 · posted 2024-11-22 · Open, Classified

Recall details

Recalling firm

MicroSurgical Technology Inc

Reason for recall

Due to pin coming off of handles.

Action taken

On 09/24/2024, the firm sent via express mail a customer letter informing customers that there is a potential issue pertaining to the pins on the handle of the DFH-1028, Handle Assembly Lot Number 160458. The locking pins that actuate the head may be defective and could potentially dislodge without warning. As a precautionary measure, the firm is replacing the handle associated with the affected lot number 160458 at no cost to customers. Customers are being instructed to return the affected products using the supplied return shipping label. Firm's contact information if questions or further assistance is needed: David Wang Sr. VP of Ops QA/RA D: 206-402-1146 8415 154th Avenue NE | Redmond, WA 98052 www.microsurgical.com dwang@microsurgical.com

Root cause

Process control

Status

Open, Classified

Product code

HNF

Quantity affected

24

Distribution

U.S.: CT, GA, MN, MT and TX. O.U.S.: Netherlands 24 total devices = 6 devices distributed in the United States and 18 devices distributed in Germany.

Date initiated

2024-09-17

Date posted

2024-11-22

Location

Redmond, WA