(b)(4).D10 medical devices: nexgen 14mm height size c,d with locking screw yellow articular surface catalog#: 00599403014, lot#: 62938369.Nexgen left size d cemented option femoral component catalog#: 00599401491, lot#: 63746608.Nexgen 18mm diameter 100mm length straight stem extension catalog#: 00598801018, lot#: 63282086.Nexgen stemmed tibial component precoat size 3 catalog#: 00598003701, lot#: 63544274.Nexgen 14mm diameter 100mm length offset stem extension catalog#: 00598802014, lot#: 63632065.Prc agmt block dist sz d 5mm catalog#: 00599003410, lot#: 62963054.Prc agmt block dist sz d 5mm catalog#: 00599003410, lot#: 62999435.Competitor bone cement catalog#: unk, lot#: unk.G2 foreign source: new zealand.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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