See c-(b)(4) eleven shelf cartons of product 72200724 (65 individual burrs; 10 cartons of 6 and one carton of 5) were returned from lot 50741489.They are all new and unsealed.The product used in the procedure was not returned for evaluation.Definitive conclusions, accurate investigation and evaluation were not definitive without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.
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