TEI Biosciences PriMatrix recall: Missing pages in instructions may cause confusion
TEI Biosciences recalls PriMatrix devices with missing or duplicate pages in English instructions. Affected lots manufactured Feb 2017-May 2017. Check your product lot number to see if you're affected.
Lower-risk 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.
Contact the company
What happened, in plain English
TEI Biosciences is recalling PriMatrix dermal tissue matrices that have missing or duplicate pages in their English-language instructions. This could cause confusion during surgical use, but the device itself is safe if used with the correct instructions. Read more at govinfonow.com/recall/73838-tei-biosciences-primatrix-recall-missing-pages-in-instructions-may-cause.
Source Summary by GovInfoNow · govinfonow.com/recall/73838-tei-biosciences-primatrix-recall-missing-pages-in-instructions-may-cause · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0383-2018
Cite this page
“TEI Biosciences PriMatrix recall: Missing pages in instructions may cause confusion.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/73838-tei-biosciences-primatrix-recall-missing-pages-in-instructions-may-cause. Based on FDA recall #Z-0383-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0383-2018%22&limit=1).
Why it’s dangerous
The instructions for use (IFUs) for some lots contain missing pages or duplicate pages that include critical information like indications for use, contraindications, and warnings. This could lead to confusion during surgery if the surgeon doesn't have complete instructions.
Who’s affected
Surgeons and medical professionals who use PriMatrix devices with affected lot numbers (manufactured February 2017 to May 2017) are most at risk. Patients using the device with proper instructions are not affected.
How to tell if you have this one
Check your PriMatrix product's lot number, which is listed on the packaging. Affected lots were manufactured between February 2017 and May 2017 and expire between 2020 and 2021.
- Brand
TEI Biosciences- Category
Medical device
What to do — step by step
Check Product Lot Number
Look for the lot number on your PriMatrix device packaging to determine if it's affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0383-2018 (June 15, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0383-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.