TEI Biosciences recalls PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a va

Recalled January 24, 2018 · FDA recall Z-0383-2018 · TEI Biosciences

Hazard

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. · FDA Class II

Units

4081 units

Sold at

U.S.

Description

Product

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(s)

TEI Biosciences

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →