PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry wi
FDA device recall Z-2447-2010 · posted 2010-09-21 · Terminated
Recall details
- Recalling firm
- Synovis Surgical Inovation Div. of
- Reason for recall
- Synovis Surgical Innovations is voluntarily recalling PSD Gel that's provided with Peri-Strips Dry Staple Line Reinforcement with Apex Processing (PSD) and Peri-Strips Dry with Veritas Collagen Matrix Staple line Reinforcement (PSD-V) products. Internal investigation have shown there is a potential for small defects in the PSD gel tube pouch which may compromise the sterility of the outside of t
- Action taken
- Consignees were sent on 6/30/10 a Recall Notification letter dated June 30, 2010. The letter was addressed to "Risk Manager". The letter described the problem and product involved. They listed both the device and gel lot numbers since it is possible that some hospitals have separated the pouched gel tubes from the PSD/PSDV products. They advised consignees to quarantine the affected lots and to complete and fax the attached "Product Return/Replacement" form to Synovis Surgical Innovations.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- 3,989 gel tubes and 1,395 PSD & PSDV devices.
- Distribution
- Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL,IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV
- Date initiated
- 2010-06-30
- Date posted
- 2010-09-21
- Date terminated
- 2011-12-17
- 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 |
|---|---|---|
| PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT (K040415) | Synovis Surgical Innovations | 2004-04-14 |