(b)(4).Concomitant medical products: palacos cement catalog b6031993 lot 76054329, palacos cement catalog b6031993 lot 76054329, palacos cement catalog b6031993 lot 75554341, nexgen articular surface catalog 00588006014 lot 62157558, nexgen stem extension catalog 00598801014 lot 62389721, nexgen stem extension catalog 00598801015 lot 62339053, synplug size 16 reference 804022 lot 2008658, synplug size 16 reference 804022 lot 2008658, tibial component catalog 00588000600 lot 62178374.(b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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