Events

Recall of Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synovis Surgical Inovation Div. of.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    37671
  • Event Risk Class
    Class 2
  • Event Number
    Z-0962-2007
  • Event Initiated Date
    2007-03-16
  • Event Date Posted
    2007-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-02-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51280
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Surgical Mesh - Product Code FTM
  • Reason
    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
    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.

Device

Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV)
  • Model / Serial
    5713060-221868, 5713061-221869, 5714567-250264, 5712862-215844, 5715407-268139, 5717353-310944-001, 5717354-310947-002, 5717355-310948-003,  5717356-310950-004, 5717357-310951-005,  5717358-310953-006, 5717359-310954-007,  5717360-310955-008, 5717361-310956-009,  5717362-310957-010, 5717403-311742-017,  5717404-311743-018, 5717405-311744-019 ,  5717406-311745-020, 5717407-311746-021,  5717408-311747-022, 5717409-311748-023,  5717410-311749-024, 5717411-311750-025,  5717412-311751-026, 5717413-311752-027,  5717414-311753-028, 5717415-311754-029,  5717416-311755-030, 5717397-311734-011,  5717398-311737-012, 5717399-311738-013,  5717400-311739-014, 5717401-311740-015,  5717402-311741-016, 5717417-311756-031,  5717418-311757-032, 5717578-314896-033,  5717579-314897-034, 5716064-280283, 5716065-280284, 5717580-314898-035, 5717581-314999-036,  5717582-314901-037, 5717583-314902-038,  5717584-314903-039, 5717585-314904-040,  5717586-314905-041, 5717587-314906-042,  5717588-314907-043, 5717589-314908-044,  5713061-396028, 5713061-396088, 5714567-395788, 5714567-396037, 5714567-396041, 5714567-396047, 5714567-396085, 5714567-396831, 5714567-408289, 5716453-285027. EXPANDED LOT/SERIAL #'s: 5716453-285027, 5716453-577195.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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
  • Product Description
    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, ( PSD 29-E-V), 29 mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
  • Manufacturer
    Synovis Surgical Inovation Div. of

Manufacturer

Synovis Surgical Inovation Div. of
  • Manufacturer Address
    Synovis Surgical Inovation Div. of, 2575 University Ave W, Saint Paul MN 55114-1073
  • Source
    USFDA