This user facility is outside of the united states.Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in (b)(4) manufactures a similar device in the united states under 510k number p010014.Examination of returned device found no evidence of product non-conformance.Root cause of the event was most likely attributed to third party debris; however, a conclusive determination could not be made.The device performed as intended.
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