Batch review performed on 24 july 2018.Lot 154620: (b)(4) items manufactured and released on 16 december 2015.Expiration date: 2020-11-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Visual inspection performed on the 18th july 2018 by washing & packaging manager and technical director, assisted by medacta complaint specialist.The device was inspected and the presence of a black sign is confirmed.The black sign is likely to be caused by a too high force applied to the measuring gauge used to control the ball head cone depth just before the packaging.The jig used for this lot of femoral heads was made of black pom-c, a plastic medical grade material, and the 'drop' signs is likely to be due to the evaporation of the alcohol used to sanitize it prior to use.From the june 2017 this gauge is no longer used and it has been replaced by a stainless steel caliber.
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