(b)(4).Concomitant medical products: disposable mixing bowl and spatula cat#00504901100 lot#64545160 ¿ 19 total quantity.Report source: (b)(6).Visual evaluation of the returned products confirmed the presence of blue particles inside the sealed pouch for 14 out of the 20 units.Fourteen units contains 1 loose blue particle each, six units contains no particles.All the blue particles have a size greater than 0.60 sq.Mm.The complaint is confirmed.Review of the device history record(s) for item #00504901100, lot #64545160 identified no deviations or anomalies related to the reported issue during manufacturing.The likely condition of 14 of the 15 units alleged against when they left zimmer biomet control is considered non-conforming.The loose blue particles likely came from the excess flash generated during the molding process of the mixing bowl and/or during the trimming of this excess flash.The fifteenth unit alleged against was found to be conforming to specifications.The root cause of the reported issue is attributed to a manufacturing issue.The event is being reviewed through the capa process.Multiple reports were filed for this event; please see associated reports: 0001822565-2020-02928, 0001822565-2020-02930, 0001822565-2020-02931, 0001822565-2020-02932, 0001822565-2020-02933, 0001822565-2020-02934, 0001822565-2020-02935, 0001822565-2020-02936, 0001822565-2020-02937, 0001822565-2020-02938, 0001822565-2020-02939, 0001822565-2020-02940, 0001822565-2020-02941.
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