Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PriMatrix¿ is an acellular dermal tissue matrix derived from fetal Recalled by TEI Biosciences Due to During Final Assembly Operation, it was noticed that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact TEI Biosciences directly.
Affected Products
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.
Quantity: 4081 units
Why Was This 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.
Where Was This Sold?
U.S.
About TEI Biosciences
TEI Biosciences has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report