KeriMedical SA, FSN-06072022-NCI514, KERILOCK SCREWED SUTUR ANCHOR KITS 2.0 AND 4.0

We have detected a partial mix-up between batches 20-0629 (2.0) and 20-0631 (4.0) leading toa labelling error. This error is due toa mix of products trom these batches processed at our packaging subcontractor during the same period, between the packaging and labeling stages, and would correspond toa reversal of the storage box(es). Hence the presence on the market of Kerilock® 2.0 with a 4.0 suture and Kerilock® 4.0 with a 2.0 suture. We are therefore initiating a recall action on these two lots to immediately correct this non-compliance.

As a precautionary measure, we are also recalling lots 20-0627 and 20-0628 Kerilock® 2.0, although no non-conformity was found on these two batches after performing stock control and there was no customers feedback but they were produced during the same period by our packaging subcontractor. To date, we have not been able to obtain sufficient documented evidence to reasonably exclude them from the scope of this recall.