PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis
Medical device recall Z-0383-2018. Published in FDA’s Enforcement Report on Jan 24, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jan 24, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 4081 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
4081 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,066 characters
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.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 15, 2017.
- FDA classified it on Jan 17, 2018.
- FDA’s Enforcement Report published it on Jan 24, 2018.
- FDA terminated it on Mar 15, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- TEI Biosciences, of Boston, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.