Why were these Exactech implants recalled?
Each of the recalled Exactech knee, ankle, or hip replacements contained a polyethylene plastic insert, which were packaged in defective vacuum bags.
One of the packaging layers for these plastic inserts had been “out of specification” and may have allowed oxygen from the air to diffuse into the plastic inserts prior to being implanted in patients.
If a large amount of oxygen diffuses into the plastic insert prior to implantation, this can lead to a process called oxidation. Oxidation can cause plastic to wear out earlier than expected or to become damaged after it is implanted inside the patient’s body.
Possible Exactech Implant Complications
The FDA classified the Exactech recall as a Class 2 recall, which is a situation where exposure to a product may cause temporary or medically reversible adverse health consequences.
Injuries may include:
- bone loss
- debris production
- component cracking
- fracture or fatigue
- revision surgery
- severe pain
- grinding or clicking noises
- instability in the joint
Exactech Implant Lawsuits | Get Help Today
If you had an Exactech knee, ankle, or hip implant after 2004 and suffered complications, please contact the Exactech recall lawyers at Martin, Harding, & Mazzotti, LLP today for a free case evaluation.