Surgical forceps and scissors handles recalled due to pin detachment
MicroSurgical Technology is recalling MST Duet Reusable Handles for surgical forceps and scissors due to pin detachment risk. Six units distributed in the US; 18 internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device recall for a mechanical failure (pin detachment) affecting surgical forceps and scissors handles. No illnesses or injuries have been reported, but a detached pin during surgery could compromise instrument function and patient safety, meeting the criterion for risk-of-harm products without reported injury.
Plain-English summary
MicroSurgical Technology Inc. is recalling the MST Duet Reusable Handle for Single Use Heads (model DFH-1028, lot number 160458). This reusable surgical handle is designed to work with interchangeable single-use forceps or scissors heads used in surgical procedures.
The handles are being recalled because the pin may come off during use. A detached pin could compromise the function of the instrument and affect its use during surgery.
Six devices were distributed in the United States (Connecticut, Georgia, Minnesota, Montana, and Texas). An additional 18 devices were distributed internationally, primarily in Germany. The affected devices have product codes HNF or HNR.
Healthcare facilities and healthcare professionals who have received these devices should stop using them immediately. Contact MicroSurgical Technology Inc. for instructions on device replacement or return.
The recalled product
- 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…
- Manufacturer
- MicroSurgical Technology Inc
- Affected units
- 24
Distribution
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