Pelvic floor repair device may lack required packaging component
FEMSelect Ltd is recalling 141 units of the EnPlace trans-vaginal pelvic floor repair system because certain lots may not have been packaged with the required Channel Tube Limiter accessory.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a missing functional component (Channel Tube Limiter) of a surgical device. Although no illnesses or injuries have been reported, the missing accessory represents a risk-of-harm product where the missing component could affect proper device handling and deployment during pelvic floor repair procedures.
Plain-English summary
The EnPlace is a single-use trans-vaginal pelvic floor repair system designed for attaching sutures to ligaments of the pelvic floor during surgical repair. The device includes anchors pre-loaded in the device shaft. The Channel Tube Limiter is a supplied accessory intended to serve as a guide channel for proper handling of the device.
Certain lots of the EnPlace may not have been packaged with the Channel Tube Limiter accessory. The absence of this component could affect the proper handling and deployment of the device during the procedure.
The recall affects 141 units distributed nationwide in Georgia. The affected lot numbers are 21072510 and 21072512. Healthcare facilities and surgical practitioners who have received affected units should verify the presence of the Channel Tube Limiter before use and contact FEMSelect Ltd with any concerns.
The recalled product
- 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…
- Manufacturer
- FEMSelect Ltd
- Affected units
- 141
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI (01)07290017 08201 1 (10) YYMMDDXX (11)YYMMDD (17)YYMMDD
- Lot Numbers: 21072510 and 21072512.
Distribution
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