Exactech Knee, Ankle, and Hip Insert Recall
On February 7, 2022, Exactech sent an Urgent Medical Device Correction notice to knee and ankle surgeons, hospitals, and healthcare professionals. According to Exactech, inserts manufactured since 2004 were packaged in non-conforming vacuum bags. Although the bags are oxygen resistant, they do not feature a secondary barrier layer of ethylene vinyl alcohol (EVOH). The purpose of EVOH is to bolster the device’s resistance to oxygen.
The added oxygen can cause degradation of the UHMWPE, prompting the following:
Accelerated wear debris production
Bone loss • Disintegration of bone cells (lysis)
Component fatigue cracking/fracture
Necessary corrective revision surgery