(b)(4).Concomitant medical devices: item #: unknown, unknown head, lot #: unknown; item #: unknown, unknown stem, lot #: unknown; 110010242 g7 osseoti 3 hole shell 48mm c 6781911; 110024461 g7 dual mobility liner 38mm c 821470; 00625006515 bone scr 6.5x15 self-tap 64676690; 00625006540 bone scr 6.5x40 self-tap j6704298; 00625006520 bone scr 6.5x20 self-tap 6557304.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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