TIBIAXYS — Class II medical device recall Z-2447-2018
Terminated recall by NewDeal SA, reported 2018-07-25, distributed in CA, CO, CT, ID, KS, MA, MD, MN…. Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep
| Recall number | Z-2447-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NewDeal SA, St Priest, France |
| Recall initiated | 2018-05-22 |
| Classified | 2018-07-16 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2019-11-04 |
| Distributed | CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA, WI |
| Lot numbers | 150020S, 150240S, 150260S, 150265S, 150270S, 150290S, 150514S, EA0T/G, EB5W/G, EB7X/G, F6R7, F6R8, F6R9-F8X7, F6RA, F6RB, F6RR, F6RS, F6RU, F6RV, F6RW, F6RX, F6RY, F6RZ, F6S0, F6S1, F6S2, F6S3, F6W9, F6WA, F6YN, F6YN/1, F6YN/2-F6YN/3, F6YN/4, F6YN/5, F6YN/A, F77H, F77J, F77K-F9MJ, F7PB-F9KG, F7X0 and 72 more |
| Model numbers | 150010S, 150020S, 150030S, 150040S, 150110S, 150120S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S, 150516S |
Product
TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
Reason for recall
Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.
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-2447-2018. 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.