Recall Z-1570-2023— New Wave Endo-Surgical, Corp.
Class II · Terminated
Class II FDA medical device recall by New Wave Endo-Surgical, Corp., initiated 2020-07-08, terminated 2024-07-02. FDA's recall record names no specific 510(k) clearance for this event. Product: M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall. Reason: The plastic housing on the device may fracture.
- Recalling firm
- New Wave Endo-Surgical, Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-08
- Terminated
- 2024-07-02
- Firm location
- Coconut Creek, FL, United States
Product description
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Reason for recall
The plastic housing on the device may fracture
Data sourced from openFDA. This site is unofficial and independent of the FDA.