# FDA recall Z-2070-2023

> **TEI Biosciences, Inc.** · Class II · device recall initiated 2023-05-23.

## Product

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20 cm Thin Semi-Oval, 6x16 cm Semi-Oval, Thin Oval 8x12 cm, Thin Oval 10x15 cm, Meshed 20cm x 10cm

## Reason for recall

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

## Distribution

Domestic: Nationwide Distribution.

## Key facts

- **Recall number:** Z-2070-2023
- **Recalling firm:** TEI Biosciences, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-23
- **Report date:** 2023-07-12

- **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-2070-2023

## Citation

> AI Analytics. FDA recall Z-2070-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2070-2023. Source: US FDA. Licensed CC0.

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