Z-0383-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2018
- Initiation Date
- June 15, 2017
- Termination Date
- March 15, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4081 units
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.
Reason for Recall
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.
Distribution Pattern
U.S.
Code Information
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.