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Terminated

Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable surgical mesh comprised of non-crosslinked bovine pericardium in a dehydrated form. Do not reuse. Consult Instructions for Use. Sterilized. Product treated with sodium hydroxide. Produt derived from USDA-inspected cattle. Made in the U.S.A. Rx Only. Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., 6575 University Ave W., St. Paul, MN 55114-1024 USA. 651 796-7300, 800.487.9627

FDA Recall Z-0892-05 · Posted 2005-06-14

Recalling FirmSynovis Surgical Inovation Div. of
Recall StatusTerminated
Product CodeFTM
Date Initiated2005-05-23
Date Terminated2005-11-17
Product Quantity56 boxes each box containing 6 pouches

Reason for Recall

Device is contained in 2 pouches. The outer pouch's seal may be compromised; this may render the exterior of the interior pouch non-sterile.

Firm Action

The sites and/or distributors that received the suspect devices were contacted by telephone and given instruction how to return/replace the devices. A Recall Notice, dated 05/31/05, was also sent to customers indicating the model number(s) and quantities of affected product which the institution received and the amount they were to return.

Root Cause

Other

Distribution Pattern

AK, AL, AZ, CA, DE, FL, GA, MO, OR, TN, TX, VA and WA

Official Source

View FDA Recall →

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

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