Recall Z-2492-2021 ยท KNW Instrument, Biopsy
M.D.L. S.r.l.
Soft Tissue Biopsy Needles
| Date | Aug 5, 2021 |
| Status | Terminated |
| Reason | Sterility assurance may be compromised. |
| Root cause | Other |
| Action | The firm disseminated an URGENT: MEDICAL DEVICE RECALL notice on 08/05/2021 by email. The notice explained the issue and requested the return of any unused products. Distributors were instructed to notify their customers. |
| Quantity | 20,129 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, M.D.L. S.R.L., Oct 27, 2016 |