FDAFDA · Food and drugs·Recall number Z-2076-2023
SurgiMend PRS Meshed; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Size 10cm x 20cm
Published July 12, 2023 · Recall initiated: May 23, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- TEI Biosciences, Inc.
- Distributor
- Domestic: Nationwide Distribution.
- Lot
- Item No. 606-907-001. No UDI-DI (Distributed in Canada and EU).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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