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SurgiMend®
TEI BIOSCIENCES INC. · Model 606-005-003 · UDI-DI 10381780112952
FTM
Prescription
1
510(k) clearances
11,622
Adverse events (48 deaths)
76
Recalls
89
Facilities
Description
SurgiMend is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes, shapes, and thicknesses to be trimmed by the physician to meet the individual patient's needs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
| 2024-08-07 | Cook Biotech, Inc. | Products expire prior to the expiration date printed on the product labeling |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.