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
1Lot # 20LP02813, Serial #D147 to D149
2Lot # 20LP02812, Serial # D115 to D119
3Lot # 20LP02816, Serial # D099 to D114
4Lot # 20HP01926, Serial # D059 to D065
5Lot # 20LP02819, Serial # D175 to D198
6Lot # 20LP02818, Serial # D129 to D146
7Lot # 20LP02815, Serial # D120 to D128
8Lot # 20MP03078, Serial # D374
9Lot # 20HP01927, Serial # D278 to D282
10Lot # 20MP03037, Serial # D294 to D296
11Lot # 20LP02827, Serial # D199 to D258
12Lot # 20 MP03036, Serial # D288 to D293
13Lot # 20MP03077, Serial # D370 to D373
14Lot # 20MP03035, Serial # D259 to D277
15Lot # 20MP03041, Serial # D283 to D287
16Lot # 20MP03049, Serial # D343 to D369
17Lot # 20MP03048, Serial # D297 to D342
18Lot # 20MP03123, Serial # D375 to D459
19Lot # 20HP01928, Serial # D460 to D474
20Lot # 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:37 PM UTC

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