(b)(4).D10 medical devices: femur trabecular metal cruciate retaining (cr) narrow porous catalog#: 42502207002, lot#: 64942712.Articular surface medial congruent (mc) right 10 mm height catalog#: 42522100910, lot#: 65073512.All poly patella standard cemented size 35 mm diameter 9.0 mm thickness catalog#: 00597206535, lot#: 65144571.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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