Total Knee Replacement Tibial Insert Recall - Exatech Optetrak Logic

ANSM registered recall action R2608390 involves a lot withdrawal of tibial inserts (Optetrak Logic) for total knee replacement surgery by manufacturer Exatech Inc. The safety alert, dated April 1, 2026, targets pharmacies d'usage intérieur (hospital pharmacies) that stock these components. Specific lot numbers affected should be identified from the manufacturer correspondence linked in the alert.

Healthcare facilities must immediately review their inventory for the affected tibial insert lot, segregate any remaining stock, and contact Exatech Inc directly using the contact information provided in the manufacturer letter. Failure to remove recalled medical devices could result in patient harm and regulatory sanctions. Facility recall coordinators should document the removal and maintain records of the recall response.