Events

Recall of Device Recall PriMatrix Dermal Repair Scaffold Instructions for Use (IFU)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by TEI Biosciences.

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
    78802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0383-2018
  • Event Initiated Date
    2017-06-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-03-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160543
  • 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
    Dressing, wound, collagen - Product Code KGN
  • Reason
    During final assembly operation, it was noticed that some of the primatrix instructions for use (ifus) from lot rm1608011 part 520-002v10 contained extra pages and/or missing pages: " 22 ifus contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 ifus were missing pages 27 - 50 " 1 ifu was missing pages 1 - 2 & 75 - 76 " 1 ifu was missing pages 15 - 62 while pages 27  50, 75  76, and 15  62 contain instructions written in a language other than english, pages 1  2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.
  • Action
    Integra LifeSciences Corporation notified (all U.S.) customers via Letter/Medical Device Correction Field Safety Notice dated June 15, 2017. Letter delivered by courier service, facsimile or email July 15, 2017.

Device

Device Recall PriMatrix Dermal Repair Scaffold Instructions for Use (IFU)
  • Model / Serial
    Product Model Number Product Lot Number Product Description Product Model Number Product Lot Number Product Description 607-004-880 1508019 8 x 8 cm 607-005-014 1702023 14mm Disc 607-005-880 1509051 8 x 8 cm 607-005-018 1702024 18mm Disc 607-005-440 1512021 4 x 4 cm 607-005-220 1702025 2 x 2 cm 607-005-812 1512022 8 x 12 cm 607-005-014 1702026 14mm Disc 607-005-440 1603044 4 x 4 cm 607-005-018 1702027 18mm Disc 607-005-660 1606038 6 x 6 cm 607-005-220 1702028 2 x 2 cm 607-001-112 1611044 10 x 12 cm 607-005-014 1702029 14mm Disc 607-001-812 1611045 8 x12 cm 607-005-018 1702030 18mm Disc 607-001-225 1612013 20 x 25 cm 607-005-220 1702031 2 x 2 cm 607-001-009 1612018 0.2 x 26.5 cm 607-005-014 1702032 14mm Disc 607-004-440 1701034 4 x 4 cm 607-005-014 1702033 14mm Disc 607-001-440 1701036 4 x 4 cm 607-005-014 1702034 14mm Disc 607-004-660 1701037 6 x 6 cm 607-005-014 1703007 14mm Disc 607-001-660 1701044 6 x 6 cm 607-005-018 1703008 18mm Disc   The affected lots are manufactured from February 2017 to May 2017.   The affected lots will expire in 2020 to 2021.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    Unclassified
  • Implanted device?
    Yes
  • Distribution
    U.S.
  • Product Description
    PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
  • Manufacturer
    TEI Biosciences

Manufacturer

TEI Biosciences