St Priest, France
NewDeal SA recalls
1 recall recorded since 2018, most recently on 22 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 May 2018
- Terminated
- 4 November 2019
- Reason
- 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
- CA, CO, CT, ID, KS, MA, MD, MN, MO, MS, NC, NY, OH, OR, PA, SD, VA, WA & WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2447-2018, Z-2443-2018, Z-2445-2018, Z-2446-2018, Z-2444-2018
- TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S &
- UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
- ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
- Large QWIX, Model Numbers: 111740S, 111745S, 111750S, 111755S, 111760S, 111765S, 111770S, 111775S, 111780S, 111785S, 111790S, 111795S, 111800S, 111805S, 111810S, 111815S, 111820S, 121740S, 121745S, 121750S, 121755S,
- ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.