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

Recall date

June 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0383-2018

FDA classification

Class II

Brand / firm

TEI Biosciences

Sold / distributed

U.S.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.