Use cautionMedical device recall · FDA · Published June 17, 2021
Ilizarov Wire Tensioner Recall: Wrong Plastic Material Could Break During Sterilization
Medicalplastic recalls Ilizarov Wire Tensioner Model 71070341 with a manufacturing error causing a wrong plastic internal washer that may wear and break during autoclave sterilization, risking malfunction.
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.
“Ilizarov Wire Tensioner Recall: Wrong Plastic Material Could Break During Sterilization.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62332-ilizarov-wire-tensioner-recall-wrong-plastic-material-could-break-during. Based on FDA recall #Z-0245-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0245-2022%22&limit=1).
The FDA announced on June 17, 2021, that Medicalplastic S.R.L. is recalling Ilizarov Wire Tensioners due to a manufacturing error that could cause the device to malfunction. The agency classified the recall as Class II.
An internal washer of the Ilizarov Wire Tensioner was made from the wrong plastic material. This error could cause the washer to wear and break during sterilization in an autoclave, leading to malfunctioning of the tensioner.
Context
GovInfoNow's records show other recent recalls of similar medical devices include the Olympus HX-400U-30 Ligating Device Recall on Oct. 30, 2025, and Medline Surgical Drapes Recall on Jan. 7, 2026. Another related recall was the Medline Convenience Kits Recall reported on Jan. 7, 2026.
How to tell if you have this one
Check for the model number 71070341 and the specific serial numbers listed in the recall notice. The product includes a unique device identifier (UDI) starting with (10)08033201842072.
Brand
Medicalplastic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Review the model number and serial numbers listed in the recall notice to confirm if your Ilizarov Wire Tensioner is affected.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “Memphis, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0245-2022 (June 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0245-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.