Reported Jul 12, 2023 · Ongoing
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm,…
TEI Biosciences, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TEI Biosciences, Inc. · 7 Elkins St · Boston, MA · 02127-1601
Is this the product you have?
- 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.
- Lot codes and dates
- Item No. (UDI-DI): 606-206-001 (10381780357339), 606-206-002 (10381780357360), 606-206-003 (10381780357346), 606-206-004 (10381780357353), 606-206-005 (10381780357377), 606-206-006 (10381780357384), and 606-206-007 (10381780357391).
- Amount recalled
- 3,992 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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