Recall Z-0521-2025 ยท HNF Scissors, Ophthalmic
MicroSurgical Technology Inc
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 u
| Date | Nov 22, 2024 (initiated Sep 17, 2024) |
| Status | Open, Classified |
| Reason | Due to pin coming off of handles. |
| Root 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 furthe |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.