Coconut Creek, FL, United States
New Wave Endo-Surgical, Corp. recalls
1 recall recorded since 2018, most recently on 8 July 2020. 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
- 8 July 2020
- Terminated
- 2 July 2024
- Reason
- The plastic housing on the device may fracture
- Distribution
- US Nationwide distribution in the states of FL, MA, and GA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1570-2023
- M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
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.