Reported Nov 24, 2021 · Ongoing
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medicalplastic S.R.L.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medicalplastic S.R.L. · Via Saverio Mercadante 15 · Milan, N/A · N/A
Is this the product you have?
- Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
- Lot codes and dates
26 of 26 products
Products covered by this recall # Product as published 1 Lot # 20LP02813, Serial #D147 to D149 2 Lot # 20LP02812, Serial # D115 to D119 3 Lot # 20LP02816, Serial # D099 to D114 4 Lot # 20HP01926, Serial # D059 to D065 5 Lot # 20LP02819, Serial # D175 to D198 6 Lot # 20LP02818, Serial # D129 to D146 7 Lot # 20LP02815, Serial # D120 to D128 8 Lot # 20MP03078, Serial # D374 9 Lot # 20HP01927, Serial # D278 to D282 10 Lot # 20MP03037, Serial # D294 to D296 11 Lot # 20LP02827, Serial # D199 to D258 12 Lot # 20 MP03036, Serial # D288 to D293 13 Lot # 20MP03077, Serial # D370 to D373 14 Lot # 20MP03035, Serial # D259 to D277 15 Lot # 20MP03041, Serial # D283 to D287 16 Lot # 20MP03049, Serial # D343 to D369 17 Lot # 20MP03048, Serial # D297 to D342 18 Lot # 20MP03123, Serial # D375 to D459 19 Lot # 20HP01928, Serial # D460 to D474 20 Lot # 20MP03126, Serial # D482 to D491 - Amount recalled
- 581 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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