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Reimbursement / Regulatory

ConforMIS Provides Update on Post-Voluntary Recall Activities -

ConforMIS substantially completed its investigation of excess moisture and ethylene glycol residue on specific serial numbers of patient-specific instrumentation for iUni, iDuo, iTotal CR and iTotal PS knee replacement product systems, previously announced in mid-3Q15. An independent testing laboratory determined that the ethylene glycol residue on the affected instrumentation posed no significant health hazard to patients, and found that no residue was present on any implants tested. ConforMIS believes that no monitoring of patients is necessary.

Investigation results suggest that the affected instrumentation underwent ethylene oxide sterilization in the presence of excess water and thus contained small amounts of ethylene glycol residue. ConforMIS is completing final testing and implementing corrective actions, and expects to resume full production in October.

Source: ConforMIS, Inc.

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