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
  • 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
  • 1 Event

Manufacturer