A visual and functional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation.The device history record (dhr) of batch number 02l1302324 that belongs to catalog number 780-35kit has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports (ncmr) were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on similar complaints for "limbs reversed", a non-conformance has been issued in order to review current production, to identify, a root cause, and implement corresponding corrective actions.
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