The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
Reason for recall: The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process. Distribution: US Nationwide distribution in the states of FL, GA, KS, OH, WI. Quantity: 8 units Lot/code info: Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
04026575310203
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.