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OmniPore Surgical Implant

MATRIX SURGICAL HOLDINGS, LLC · Model OP8438 · UDI-DI 00855421005017

KKY
1
510(k) clearances
215
Adverse events (2 deaths)
9
Recalls
11
Facilities

Description

Micro Thin Sheet

Recalls

DateFirmReason
2019-01-30Matrix Surgical Holdings, LLCProduct mislabeling.
2019-01-30Matrix Surgical Holdings, LLCProduct mislabeling.
2017-01-25Matrix Surgical Holdings, LLCMislabeling. The packaging labeled as left mandible contained a right mandible.
2016-06-13Biomet Microfixation, LLCPotential sterility deficiency.
2013-12-06Stryker 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.
2008-10-24Stryker Craniomaxillofacial DivisionLack of assurance of sterility.
2008-10-24Stryker Craniomaxillofacial DivisionLack of assurance of sterility.
2008-10-24Stryker Craniomaxillofacial DivisionLack of assurance of sterility.
2008-10-24Stryker Craniomaxillofacial DivisionLack of assurance of sterility.

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Data 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.