Maldon, United Kingdom
ORTHO SOLUTIONS, LTD. recalls
1 recall recorded since 2018, most recently on 10 October 2017. 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
- 10 October 2017
- Terminated
- 31 August 2018
- Reason
- Following the identification of corrosion residue found inside the cannulated devices in Forefoot and Midfoot trays Orhto Solutions Group has taken the decision to recall ALL x106 System 26 Forefoot and Midfoot Implants and Instruments tray from the US market.
- Distribution
- U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0967-2018
- SYSTEM 26. Part Numbers: OS900035-NS; OS900036-NS; OS900037-NS; OS900038-NS; OS900040-NS; OS900041-NS; OS900042-NS; OS900043-NS; OS900047-NS; OS900048-NS; OS900045-NS; OS900046-NS; OS900050-NS; OS900051-NS;
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.