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

SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin. — recall Z-2071-2023

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-2071-2023
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)
10381780112952
Reported risk: Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.