Class 2 Device Recall MST Duet Reusable Handle for Single Use Heads

• Date Initiated by Firm: September 17, 2024
• Date Posted: November 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0521-2025
• Recall Event ID: 95572
• Product Classification: Scissors, Ophthalmic - Product Code HNF
• Product: Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.
• Code Information: Lot Code: Product Codes: HNF or HNR (Regulation Number 886.4350). Either code can apply as the Duet Handle Assembly can be used with MST Duet Ophthalmic Scissors or MST Duet Forceps. UDI: 00844685005536 Lot #: 160458. Lot number is a sequential number generated through the internal SAP. All finished goods can be effectively traced by the lot number as either the finished good part or the sub part used. Expected life: The number of handle reprocessing cycles is not limited as long as the post-cleaning and pre-use inspections determine that the product is still functional and shows no signs of damage or corrosion.
• Recalling Firm/ Manufacturer: MicroSurgical Technology Inc; 8415 154th Ave Ne; Redmond WA 98052-6482
• For Additional Information Contact: Marybeth Porter; 425-2846094
• Manufacturer Reason for Recall: Due to pin coming off of handles.
• FDA Determined Cause: Process control
• Action: 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
• Quantity in Commerce: 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.
• 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.