Z-0245-2022Class II

Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434

Name: Z-0245-2022 Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Creator: Medicalplastic S.R.L.
Published: 2021-06-17
License: https://open.fda.gov/license/

Medicalplastic / initiated 2021-06-17 / Open, Classified / root cause: manufacturing process

FDA source

Medicalplastic S.R.L. began a recall of Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434 on 2021-06-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0245-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-17
Posted: 2021-11-17
Recalling firm: Medicalplastic
Product: Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 581 units
Distribution: Memphis, TN
Product codes and lots: 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 ;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0245-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0245-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-17

Product code KTT

K093047Class IISmith & Nephew Circular Fixation SystemSmith & Nephew, Inc. / cleared 2010-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)