Pma/510k: device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D4: specific lot remains unknown.Lots 2579141, 2531940, 2725508 are suspected lots.Part: 253.330, lot: 2579141, manufacturing site: bettlach, release to warehouse date: march 8, 2010.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part: 253.330, lot: 2531940, manufacturing site: bettlach, release to warehouse date: october 8, 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Part: 253.330, lot: 2725508, manufacturing site: bettlach, release to warehouse date: april 12, 2011.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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