Z-0383-2018Class II

PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied...

Name: Z-0383-2018 PriMatrix is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied...
Creator: TEI Biosciences
Published: 2017-06-15
License: https://open.fda.gov/license/

Integra LifeSciences Braintree Inc. / initiated 2017-06-15 / Terminated / root cause: labeling and UDI

FDA source

TEI Biosciences began a recall of 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... on 2017-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0383-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-15
Posted: 2018-01-17
Terminated: 2018-03-15
Recalling firm: Integra LifeSciences Braintree Inc.
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.
Product code: KGN Wound Dressing With Animal-Derived Material(S)
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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.
Quantity in commerce: 4081 units
Distribution: U.S.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0383-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0383-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-17

Product code KGN

K153690UnclassifiedPriMatrix Dermal Repair ScaffoldTei Biosciences, Inc. / cleared 2016-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)