Medicalplastic S.R.L. Recall 88785
Description: Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medicalplastic S.R.L. Recall 88785 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0245-2022 |
| Event ID | 88785 |
| Event Description | Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434 |
| Product Type | Devices |
| Distribution | Memphis, TN |
| Quantity | 581 units |
| Recall 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. |
| Device Classification | 20211124 |
| Device Code Info | Lot # 20LP02813, Serial #D147 to D149; Lot # 20LP02812, Serial # D115 to D119 ; Lot # 20LP02816, Serial # D099 to D114 ; Lot # 20HP01926, Serial # D059 to D065 ; Lot # 20LP02819, Serial # D175 to D198 ; Lot # 20LP02818, Serial # D129 to D146 ; Lot # 20LP02815, Serial # D120 to D128 ; Lot # 20MP03078, Serial # D374 ; Lot # 20HP01927, Serial # D278 to D282 ; Lot # 20MP03037, Serial # D294 to D296 ; Lot # 20LP02827, Serial # D199 to D258 ; Lot # 20 MP03036, Serial # D288 to D293 ; Lot # 20MP03077, Serial # D370 to D373 ; Lot # 20MP03035, Serial # D259 to D277 ; Lot # 20MP03041, Serial # D283 to D287 ; Lot # 20MP03049, Serial # D343 to D369 ; Lot # 20MP03048, Serial # D297 to D342 ; Lot # 20MP03123, Serial # D375 to D459 ; Lot # 20HP01928, Serial # D460 to D474 ; Lot # 20MP03126, Serial # D482 to D491 ; Lot # 20MP03125, Serial # D492 to D522 ; Lot # 20MP03124, Serial # D475 to D481 ; Lot # 21BP00265, Serial # D523 to D574 ; Lot # 21BP00266, Serial # D626 to D672 ; Lot # 21BP00271, Serial # D588 to D625 ; Lot # 21BP00272, Serial # D575 to D587 ; |
| Center Classification Date | 20211117 |
| Recall Initiation Date | 20210617 |
| Recalling Firm | Medicalplastic S.R.L. |
| Initial Notification | |
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