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Brand Name: MST Duet Reusable Handle for Single Use Heads recallZ-0521-2025 · MicroSurgical Technology Inc · initiated Sep 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MicroSurgical Technology Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Due to pin coming off of handles.

FDA root cause category: Process control

What the company is doing

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 [email protected]

Recall details

Recall number
Z-0521-2025
Status
Open, Classified
Initiated by the company
Sep 17, 2024
Posted by the FDA
Nov 22, 2024
Recalling firm
MicroSurgical Technology Inc
Quantity
24
Product code
HNF
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.

Product description

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 (models, lots, serial numbers)

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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