ClearanceBrief
Recall Z-2447-2010 ยท DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Synovis Surgical Inovation Div. of

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. Sterile, Rx only, Synovis Surgical Innovations. Intended to be used as a staple line buttress.

DateSep 21, 2010 (initiated Jun 30, 2010)
StatusTerminated
ReasonSynovis 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
Root causePackaging
ActionConsignees 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.
Quantity3,989 gel tubes and 1,395 PSD & PSDV devices.
DistributionWorldwide 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, and WI and countries of AUSTRALIA, GERMANY, GREECE, HONG KONG, NETHERLANDS, PUERTO RICO, ROMANIA,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K040415PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT
Synovis Surgical Innovations, Apr 14, 2004