The EnPlace is a single use trans-vaginal pelvic floor recall
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.…
Why was The EnPlace is a single use trans-vaginal pelvic floor recalled?
Certain lots may not have been packaged wth the Channel Tube Limiter.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512.
- 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.…
- Recalling firm
- FEMSelect Ltd
- Quantity
- 141 units
- Distribution
- US Nationwide distribution in the state of Georgia.
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)