Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Summary
The FDA issued a Class II for Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11) by Medicalplastic S.R.L.. 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 .
Details
Source
Device Recall
External ID
Z-0245-2022
Action Date
2021-11-24
Status
Ongoing
Category
device
Product Description
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Lot/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 ;
Quantity Affected: 581 units
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.
Distribution
Memphis, TN
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-17
Company
Milan, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 144 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medicalplastic S.R.L.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medicalplastic S.R.L. have FDA actions?
This is the only FDA action we have on record for Medicalplastic S.R.L. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0245-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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