(b)(4).A2:dob 1953.G2: uk.G4 - this product is manufactured by zimmer biomet and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet in warsaw, indiana manufactures a similar device in the united states under 510k number k182516.D10 - medical product: catalog #: 118001, versa-dial/comp ti std taper, lot # 182780; catalog #: 113022, versa-dial 38x19x39 hum head, lot # 395410; catalog #: 113952, sm hybrid glenoid base 4mm, lot # 729090; catalog #: pt-113950, pt hybrid glen post regenerex, lot # 849750; catalog #: unknown, unknown, lot # unknown.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00803, 0001825034-2024-00804, 0001825034-2024-00805, 0001825034-2024-00806.
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