Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
FDA device recall Z-0524-06 · posted 2006-02-22 · Completed
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
- Action taken
- Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots. On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery.
- Root cause
- Other
- Status
- Completed
- Product code
- FTL
- Quantity affected
- 31,761 units
- Distribution
- Nationwide Foreign: Australia, Canada, Japan,
- Date initiated
- 2005-12-22
- Date posted
- 2006-02-22
- 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 |