# FDA recall Z-0383-2018

> **TEI Biosciences** · Class II · device recall initiated 2017-06-15.

## 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.

## 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.

## Distribution

U.S.

## Key facts

- **Recall number:** Z-0383-2018
- **Recalling firm:** TEI Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-15
- **Report date:** 2018-01-24
- **Termination date:** 2018-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Boston, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0383-2018

## Citation

> AI Analytics. FDA recall Z-0383-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0383-2018. Source: US FDA. Licensed CC0.

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