Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical
FDA device recall Z-0965-2007 · posted 2007-06-15 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Inovation Div. of
- Reason for recall
- Package Integrity/Sterility Compromised-The foil pouch in the Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
- Action taken
- Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.
- Root cause
- Other
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 86
- Distribution
- Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
- Date initiated
- 2007-03-16
- Date posted
- 2007-06-15
- Date terminated
- 2008-02-24
- 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 |