(b)(4).Concomitant medical products: g7 screw 6.5mm x 20mm, cat#010000997, lot#: 6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot# :6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot# :6591649.G7 screw 6.5mm x 35mm, cat#010001000, lot#:6586581.G7 screw 6.5mm x 20mm, cat#010000997, lot#:6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot#:6591649.G7 screw 6.5mm x 20mm, cat#010000997, lot#:6591649.G7 screw 6.5mm x 35mm, cat#010001000, lot#:6586581.G7 screw 6.5mm x 35mm, cat#010001000, lot#:6586581.Report source: (b)(6).Visual inspection of the returned units for lot # 6591649 found that 3 of 7 units meet the specifications and 4 of 7 units are below the 6mm specification.The reported issue is confirmed for 4 of 7 units.Visual inspection of the returned units for lot # 6586581 found that all 3 units did not meet the seal width specifications.The reported issue is confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Review of complaint history identified additional similar complaints for the reported item(s) and no additional complaints for the reported part and lot combination(s).The likely condition of the product when leaving zimmer biomet was not conforming to specifications.The root cause of the reported issue is attributed to operator error during the manufacturing process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-00506, 0001825034-2020-00508, 0001825034-2020-00509, 0001825034-2020-00510, 0001825034-2020-00511, 0001825034-2020-00512.
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