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.
FDA Recall Z-0383-2018 · Posted None
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Recalling FirmTEI Biosciences
Recall StatusTerminated
Product CodeKGN
Date Initiated2017-06-15
Date Terminated2018-03-15
Product Quantity4081 units
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.
Firm Action
Integra LifeSciences Corporation notified (all U.S.) customers via Letter/Medical Device Correction Field Safety Notice dated June 15, 2017. Letter delivered by courier service, facsimile or email July 15, 2017.
Root Cause
Error in labeling
Distribution Pattern
U.S.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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