Batch reviews performed on 20 november 2017.Lot 172512: (b)(4) items manufactured and released on 04 august 2017.Expiration date: 2022-07-24.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.Versafitcup flat pe hc liner ø 32 / c, code 01.26.3239hct, lot.172714 (k120531) (b)(4) items manufactured and released on 15 september 2017.Expiration date: 2022-08-28.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.On 23 november 2017 the r&d project manager performed a visual inspection of the retrieved items and commented as follows: the liner was analyzed: some little signs were noticed, but no particular big damages or features were noticed.Moreover, an impaction trial has been done, correctly positioning the liner into a versafitcup cc shell of the related size.The problem could be related to an incorrect alignment of the two axis (cup and liner), preventing the insertion of the liner; in any case, it is not possible to determine with certainty the root cause of the event.
|