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Omnigraft™
Integra Lifesciences Corporation · Model DFU4041 · UDI-DI 10381780125747
MDD
Prescription
0
510(k) clearances
187
Adverse events (7 deaths)
3
Recalls
4
Facilities
Description
Omnigraft™ Dermal Regeneration Matrix (Omnigraft)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-11 | Integra LifeSciences Corporation | Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for |
| 2009-01-16 | Integra LifeSciences Corp | Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained. |
| 2008-07-02 | Integra LifeSciences Corp | Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010. |
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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.