Bard Composix Kugel Hernia Patch- Large Oval with ePTFE , 5.4'' x 7.0'' Product Number: 0010202
FDA device recall Z-0359-2007 · posted 2007-01-30 · Completed
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- PET recoil ring breakage-Memory recoil ring may break which could potentially lead to bowel perforation and or chronic enteric fistula
- Action taken
- Davol Inc. notified Hospital Administrators/Risk Health Managers,distributors, and surgeons of the expanded recall by letter beginning 1/10/07. Product under recall is to be returned to Davol for replacement. Davol is posting recall information to their website.
- Root cause
- Other
- Status
- Completed
- Product code
- FTL
- Quantity affected
- 32,581 units
- Distribution
- Nationwide
- Date initiated
- 2007-01-10
- Date posted
- 2007-01-30
- Location
- Cranston, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 (K003323) | Davol, Inc. | 2001-01-22 |