Modi'in, N/A, Israel
FEMSelect Ltd recalls
1 recall recorded since 2018, most recently on 13 December 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 December 2021
- Reason
- Certain lots may not have been packaged wth the Channel Tube Limiter.
- Distribution
- US Nationwide distribution in the state of Georgia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0556-2022
- The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready fo
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.