Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2447-2010 · Posted 2010-09-21

Recalling FirmSynovis Surgical Inovation Div. of
Recall StatusTerminated
Product CodeDXZ
Date Initiated2010-06-30
Date Terminated2011-12-17
Product Quantity3,989 gel tubes and 1,395 PSD & PSDV devices.

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

Firm Action

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

Distribution Pattern

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, and WI and countries of AUSTRALIA, GERMANY, GREECE, HONG KONG, NETHERLANDS, PUERTO RICO, ROMANIA, SAUDI ARABIA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040415PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENTSynovis Surgical Innovations · 2004-04-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑