No sample was returned for evaluation.Manufacturing review of the referenced lot number and respective device history record was conducted on 6oct2021, showing that all units were quality released on 7apr2021 having met all internal qc acceptance requirements.There were no non-conformances associated with the manufacturing lot during the final packaging.Sterile subassembly lot m21a1023 (prt-20679-03) was also reviewed for potential issues impacting the quality of this product.This subassembly lot was released to component inventory on 12feb2021 having met all quality requirements including product sterility testing following eo sterilization, as well as internal bioburden and product pyrogen (lal) testing requirements.In lieu of a request for the oem supplier for a dhr review of the ecm material lots, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing.It is also noted that per the instructions for use (ifu - art-20828a) provided with the finished cangaroo envelope device, infection is listed as a potential complication associated with this procedure and device usage.
|