Independence, OH, United States
Back 2 Basics Direct LLC recalls
1 recall recorded since 2018, most recently on 29 June 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
- 29 June 2018
- Terminated
- 15 November 2018
- Reason
- Packages labeled as containing 110mm rods may contain 100mm rods.
- Distribution
- The products were distributed to the following US states: OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2881-2018
- Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B Product Usage: The Dymaxeon Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patien
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.