The notice sent to surgeons recommends against removing an Exactech device absent evidence of its failure as long as it functions properly and is not causing pain or discomfort to a recipient. The company advised physicians company to monitor patients who complain of any of the following symptoms: Knee or ankle instability.Weight-bearing issues.Noises, including grinding sound, emanating from... read more?
Exactech claims it discovered (through testing) that polyethylene components used in the total ankle, hip, and knee replacement systems were packaged and stored in “non-conforming” vacuum bags. The purpose of the bags was to limit exposure of the polyethylene or plastic components while in storage to prevent deterioration due to exposure to oxygen. The company says the vacuum bags were... read more?
Exactech identified the several devices it manufactured and sold from 2004 through 2022 as containing materials that may be defective and could cause them to fail. The following knee, ankle, and hip replacements are recalled: OPTETRAK Partial & Total Knee Replacements:
All-polyethylene CR Tibial ComponentsAll-polyethylene PS Tibial ComponentsB-Series Ps Tibial InsertCC Tibial InsertsCR Tibial... read more?