TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S...
FDA Device Recall #Z-2447-2018 — Class II — May 22, 2018
Recall Summary
| Recall Number | Z-2447-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 22, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | NewDeal SA |
| Location | St Priest |
| Product Type | Devices |
Product Description
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.
Distribution Pattern
CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
Lot / Code Information
150010S - Lot # F8X6 - F9K6 - F9YE-F9YH - FAC1 - FAFD-FBTV - FC90 - FC93-FD10 - FGL3 - FGL3/1- 150020S - Lot # F6R7 - F6R8 - F6R9-F8X7 - F8X8 - F9MH -FAA6 - FAU7 - FAU8-FAZW FAZX - FAZY-FD11 - FD12 - FFGP-F8X7 - F8X8 - F9MH -FAA6 - FAU7 - FAU8-FAZW FAZX - FAZY-FD11 - FD12 - FFGP-FGL1 - FGL2 - FH73-FH7S - FH7T & FJ4J 150030S - Lot # FGM5 FHRR 150040S - Lot # F6RA - F6RB - F7PB-F9KG FAFE - FBTT-FC91 - FGL0 - FH7U 150120S - Lot # F77H - F77J - F77K-F9MJ - F9YF - F9YG-FAA7 FAZZ - FBTU-FC92 - FCV9 - FFGR-FGGY FGGZ - FGM8-FGM9 - FH7W - FHK2 150110S - Lot # F97D - F9KH - FAU9-FCN0 FGGW - FGM7-FH7V & FJ4G 150130S - Lot # EB5W/G - EDJX/G FAUA - FG0J & FJ4J 150200S - Lot # F6RR - F7X0 - F98B-FAWZ - FD8L - FD8M-FE2T - FEX8 150240S - Lot # F6RS - F88U - F9F1-FBBS - FD8N - FD8P-FE2U - FE2V - FE2W-FEX9 - FF1M - FFPT-FGNW - FGNX & FGNY 150242S - Lot # F6RU - F88V - F98F-FAX0 - FCB9 - FE2X-FE2Y - FE2Z - FF1N-FFPU FFPV - FGNZ-FGX2 & FG7K 150246S - Lot # F6RV - F88W - F9F2-FBBT FCBA - FD8Q-FE30 - FE31 - FE32-FE33 FEXA - FF1P-FFPW - FG7L - FGP0-FGX3 150250S - Lot # F6RW - F88X - F9F3-FBBU FCPQ - FDSB-FDSC - FE34 - FE35-FEXB - FF1Q - FFPX -FG7M - FG7N - FGX4 & FHGG 150255S - Lot # F6YN - F6YN/1 - F6YN/2-F6YN/3 - F6YN/4 - F6YN/5 - F6YN/A--- 150260S - Lot # F6RX - F7X1 - F8XU-F9F5 - FAX1 - FBBV-FCPR - FD8R - FE36-FE37 - FF1R - FFPY-FG7P 150265S - Lot # F6RY - F88Y - F989-F9F6 - F9VA - FCBB-FDSD - FE38 - FFPZ-FG7Q - FH2T- 150270S - Lot # F6RZ - F8LD - F9BX-F9VB FBBW - FD8S-FE39 - FF1S - FG7R & FHGJ 150275S - Lot # F6S0 - F88Z - F98A-F9BW FBBX - FCPS-FE3A FEXC 150280S - Lot # F6S1 - F7X2 - F98D-FAPQ FBBY - FCPT-FE3B - FF1T - FG7S-- 150285S - Lot # F6S2 - F7X3 - F9F7-FBBZ - FD8T - FE3C-FF1U - FG7T 150290S - Lot # EB7X/G - F6S3 - F890-F98G - FBC0 - FCPU-FDSE - FE3D - FF1V & FH2U 150514S - Lot # EA0T/G - F6W9 - F7Z1-F8EB FAXQ - FCGX-FEHH FEXD - FG1C 150516S - Lot # F6WA - F7Z2 - F8EC-FAY4 FCGY - FEHJ-FEXE - FG1D
Other Recalls from NewDeal SA
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2443-2018 | Class II | UNI-CP, Model Numbers: 330021S, 330023S, 330025... | May 22, 2018 |
| Z-2445-2018 | Class II | ADVANSYS MLP/DLP, Model Numbers: 181051S, 18105... | May 22, 2018 |
| Z-2446-2018 | Class II | Large QWIX, Model Numbers: 111740S, 111745S, 11... | May 22, 2018 |
| Z-2444-2018 | Class II | ADVANSYS TTC, Model Numbers: 181011S, 181012S, ... | May 22, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.