FEMSelect Ltd Recall 89309
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.
FEMSelect Ltd Recall 89309 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0556-2022 |
| Event ID | 89309 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Georgia. |
| Quantity | 141 units |
| Recall Reason | Certain lots may not have been packaged wth the Channel Tube Limiter. |
| Device Classification | 20220209 |
| Device Code Info | UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512. |
| Center Classification Date | 20220202 |
| Recall Initiation Date | 20211213 |
| Recalling Firm | FEMSelect Ltd |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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