Date Initiated by Firm |
December 13, 2021 |
Create Date |
February 02, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0556-2022 |
Recall Event ID |
89309 |
510(K)Number |
K160569
|
Product Classification |
Fixation, non-absorbable or absorbable, for pelvic use - Product Code PBQ
|
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. |
Code Information |
UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD, Lot Numbers: 21072510 and 21072512. |
Recalling Firm/ Manufacturer |
FEMSelect Ltd HaMa'ayan 2 First Floor Modi'in Israel
|
Manufacturer Reason for Recall |
Certain lots may not have been packaged wth the Channel Tube Limiter.
|
FDA Determined Cause 2 |
Process design |
Action |
On Monday, December 13, 2021, FEMSelect alerted the US distributor both by phone and with a letter sent by email. The formal Recall Notice was sent on December 14, 2021. The recalling firm is requesting the return of the devices. |
Quantity in Commerce |
141 units |
Distribution |
US Nationwide distribution in the state of Georgia. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = PBQ and Original Applicant = POP Medical Solutions
|