Medicalplastic S.R.L. Via Saverio Mercadante Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Brand
Medicalplastic S.R.L. Via Saverio Mercadante
Lot Codes / Batch Numbers
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
Products Sold
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 ;
Medicalplastic S.R.L. Via Saverio Mercadante is recalling Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434 due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
TN
Page updated: Jan 10, 2026