Ilizarov Wire Tensioner — Class II medical device recall Z-0245-2022
Ongoing recall by Medicalplastic S.R.L., reported 2021-11-24, distributed in TN. Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due
| Recall number | Z-0245-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medicalplastic S.R.L., Milan, N/A, Italy |
| Recall initiated | 2021-06-17 |
| Classified | 2021-11-17 |
| Reported by FDA | 2021-11-24 |
| Distributed | TN |
| Quantity | 581 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08033201842072 |
| Lot numbers | 20HP01926, 20HP01927, 20HP01928, 20LP02812, 20LP02813, 20LP02815, 20LP02816, 20LP02818, 20LP02819, 20LP02827, 20MP03035, 20MP03037, 20MP03041, 20MP03048, 20MP03049, 20MP03077, 20MP03078, 20MP03123, 20MP03124, 20MP03125, 20MP03126, 21BP00265, 21BP00266, 21BP00271, 21BP00272, MP03036 |
| Serial numbers | D059, D065, D099, D114, D115, D119, D120, D128, D129, D146, D147, D149, D175, D198, D199, D258, D259, D277, D278, D282, D283, D287, D288, D293, D294 and 26 more |
| Model numbers | 71070341 |
Product
Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0245-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.