Recall Z-0458-2014— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2013-09-25, terminated 2016-05-06. It names one FDA 510(k) clearance: K113004. Product: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.. Reason: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-25
- Terminated
- 2016-05-06
- Firm location
- Somerville, NJ, United States
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
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Reason for recall
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.