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Gentrix®
ACELL, INC. · Model MSPL1010 · UDI-DI 00386190001950
1
510(k) clearances
3
Adverse events
1
Recalls
11
Facilities
Description
Gentrix® Surgical Matrix Plus, 10cm x 10cm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
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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.