Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2073-2023 — SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.

U.S. FDA — Device Enforcement · United States · 2023-05-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2073-2023
Date of alert
2023-05-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
TEI Biosciences, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10381780357339
Reported risk: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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