Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, Synovis Surgical Inn
FDA device recall Z-0274-2012 · posted 2011-11-23 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Inovation Div. of
- Reason for recall
- Synovis Surgical Innovations is voluntarily recalling one lot of Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V) product because some of the devices were mislabeled.
- Action taken
- Synovis Surgical Inovation sent a "Recall Notification" letter dated October 26, 2011. The letter described the problem and product affected. Customers were instructed to identify and quarantine the affected product and to complete and fax the Product Return/Replacement Form.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 132 units
- Distribution
- Nationwide Distribution including CT, GA, NJ, NY, OH, TX, VA.
- Date initiated
- 2011-10-26
- Date posted
- 2011-11-23
- Date terminated
- 2012-04-24
- 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 |