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OmniPore Surgical Implant
MATRIX SURGICAL HOLDINGS, LLC · Model OP7541 · UDI-DI 00855421005642
1
510(k) clearances
215
Adverse events (2 deaths)
9
Recalls
11
Facilities
Description
Design Y™ Mandible Onlay - Small - Left
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-01-30 | Matrix Surgical Holdings, LLC | Product mislabeling. |
| 2019-01-30 | Matrix Surgical Holdings, LLC | Product mislabeling. |
| 2017-01-25 | Matrix Surgical Holdings, LLC | Mislabeling. The packaging labeled as left mandible contained a right mandible. |
| 2016-06-13 | Biomet Microfixation, LLC | Potential sterility deficiency. |
| 2013-12-06 | Stryker Howmedica Osteonics Corp. | Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customized Implant Kit was delivered to a hospital. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
| 2008-10-24 | Stryker Craniomaxillofacial Division | Lack of assurance of sterility. |
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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.