Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement. Do not reuse. Ethylene Oxide Sterilized
FDA device recall Z-0764-06 · posted 2006-04-13 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Inovation Div. of
- Reason for recall
- The Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement devices involved have a small chance that a seal on the outer pouch may not be completely reliable.
- Action taken
- An initial phone call was placed to expedite return and replacement of product. A follow-up letter was sent. The initial phone calls to customers began on November 1, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 4,950
- Distribution
- Nationwide. AK, AZ, CA, FL, GA, IA, IL, MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and VA
- Date initiated
- 2005-11-01
- Date posted
- 2006-04-13
- Date terminated
- 2007-02-03
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VERITAS DRY COLLAGEN MATRIX, VERITAS DRY OR VERITAS PSD (K041669) | Synovis Surgical Innovations | 2004-10-27 |