Exactech Recall
Recalled Knee and Hip Replacement Parts May Cause Complications
Exactech recently issued a recall on thousands of its knee and hip replacements. Improper packaging used by the manufacturer can cause the implants to degrade prematurely, leading to pain, serious injury, and the potential need for revision surgery.
Which Exactech implants were recalled?
Affected models include:
Knee
Optetrak
Optetrak All-polyethylene CR Tibial Components
Optetrak All-polyethylene PS Tibial Components
Optetrak CR Tibial Inserts
Optetrak CR Slope Tibial Inserts
Optetrak Hi-Flex PS Tibial Inserts
Optetrak Logic
Optetrak Logic CR Tibial Inserts
Optetrak Logic CR Slope Tibial Inserts
Optetrak Logic CRC Tibial Inserts
Optetrak Logic PSC Tibial Inserts
Optetrak Logic CC Tibial Inserts
Truliant
Truliant CR Tibial Inserts
Truliant CR Slope Tibial Inserts
Truliant CRC Tibial Inserts
Truliant PS Tibial Inserts
Truliant PSC Tibial Inserts
Hip
Connexion
Connexion GXL Acetabular Polyethylene Liner
Why were these Exactech implants recalled?
Each of the recalled Exactech knee 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 or hip implant after 2004 and suffered complications, please contact the Exactech recall lawyers at Harding Mazzotti, LLP today for a free case evaluation.