Recall Z-0245-2022 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medicalplastic S.R.L.
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
| Date | Jun 17, 2021 |
| Status | Open, Classified |
| Reason | Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner. |
| Root cause | Process control |
| Action | The firm notified its sole consignee of the issue and its intent to recall by email on 06/17/2021. The recalled washers will be replaced. |
| Quantity | 581 units |
| Distribution | Memphis, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093047 | SMITH & NEPHEW CIRCULAR FIXATION SYSTEM Smith & Nephew, Inc., Sep 27, 2010 |