Ilizarov Wire Tensioner
Medical device recall Z-0245-2022. Published in FDA’s Enforcement Report on Nov 24, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 24, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Tennessee the one state its words name
- 581 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
581 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,056 characters
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 ;
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Memphis, TN
The states and territories these words name
- Tennessee
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 17, 2021.
- FDA classified it on Nov 17, 2021.
- FDA’s Enforcement Report published it on Nov 24, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medicalplastic S.R.L., of Milan, Italy.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.