Recall Z-0556-2022— FEMSelect Ltd
Class II · Ongoing
Class II FDA medical device recall by FEMSelect Ltd, initiated 2021-12-13. It names one FDA 510(k) clearance: K160569. Product: 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 for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.. Reason: Certain lots may not have been packaged wth the Channel Tube Limiter..
- Recalling firm
- FEMSelect Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-12-13
- Firm location
- Modi'in, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.
Reason for recall
Certain lots may not have been packaged wth the Channel Tube Limiter.
Data sourced from openFDA. This site is unofficial and independent of the FDA.