Recall Z-0820-2014— Davol, Inc., Subs. C. R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by Davol, Inc., Subs. C. R. Bard, Inc., initiated 2014-01-03, terminated 2015-12-23. It names one FDA 510(k) clearance: K102766. Product: Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.. Reason: Product labeling does not match product configuration..
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-03
- Terminated
- 2015-12-23
- Firm location
- Warwick, RI, 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
Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Reason for recall
Product labeling does not match product configuration.
Data sourced from openFDA. This site is unofficial and independent of the FDA.