Batch review performed on 04 april 2024: gmk-sphere 02.12.0003l femoral component sphere cemented size 3 l lot 2349204: 15 items manufactured and released on 31-jan-2024.Expiration date: 2029-01-16.Of this lot 7 items were under control in a medacta warehouse.They have been immediately opened finding the 2 remaining mixed items (the third one is the subject of this complaint).Gmk-sphere 02.12.0003r femoral component sphere cemented size 3 r lot 2348382: 15 items manufactured and released on 31-jan-2024.Expiration date: 2029-01-16.The entire lot was in medacta international warehouse.All pieces were checked confirming that 3 devices of this lot were mixed up.It means that 3 devices of the lot 2349204 (size 3l) were found in the boxes of the lot 2348382 (size 3r).Preliminary investigation performed by washing and packaging manager: the issue probably occurred when loading or unloading the implants into the biowash, a machine used for cleaning.Both batches involved are composed by 15 pieces, while the racks dedicated to wash these components (femur size 3) hold a maximum of 12 pieces.Therefore, the remaining 3 pieces were placed in another rack and during the unloading phase, 3 pieces for each lot were mixed-up.In addition, during the batch inspection, the operator did not recognise the mix up.Internal actions, including training operators and updating work instruction, have been taken to prevent a reoccurrence of the event.
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