fbpx

 

 

 

 

 

 

 

 

Exactech Knee Recall and Ankle Recall

What you need to know:

  • Over 148,000 Exactech knee replacement and ankle replacement devices have been recalled, including specific inserts used with OPTETRAK (total and partial knee replacement), TRULIANT, and VANTAGE replacement systems.
  • Exactech warns that approximately 80% of the polyethylene inserts used in its knee and ankle devices since 2004 were packaged without a necessary additional layer of oxygen-resistant protection.
  • The packaging error allows increased oxidation of the materials which can cause the inserts to degrade, leading to bone loss, component fatigue cracking/fracture, loosening, and the potential need for corrective surgeries.
  • The US Food and Drug Administration (FDA) has classified Exactech’s issue as a Class II recall.

Who is affected?

If you underwent an ankle or knee replacement surgery with an Exactech device since 2004, complete the short questionnaire to learn more.

Problems with Exactech Implants

Exactech knee and ankle devices require packaging that is oxygen resistant, including a secondary layer of protection to protect the inserts before they are implanted in the patient. Exactech has now alerted the public that certain knee and ankle replacements were packaged in vacuum bags that lacked the additional oxygen barrier, potentially causing the device to break down after it is implanted in patients, which may cause serious complications.

Complete this short questionnaire or give us a call at 800.755.0098 for a free and confidential consultation.

“Urgent Medical Device Recall” Expanded

In 2021, Exactech sent a letter titled “Urgent Medical Device Recall” to distributors and sales representatives warning that some of its inserts were packaged incorrectly because they lacked a necessary oxygen barrier. In April 2022, Exactech expanded the recall and warned surgeons and hospitals that the lack of an additional oxygen barrier in the packaging may cause the insert to breakdown over time. The expanded recall includes all Exactech poly inserts on certain knee and ankle devices manufactured since 2004.

Exactech warns that 80% of the recalled inserts may be impacted and describes the issues as follow:

“The use of these non-conforming bags may enable increased oxygen diffusion to the UHMWPE (ultra-high molecular weight polyethylene) insert, resulting in increased oxidation of the material relative to inserts packaged with the specified additional oxygen barrier layer. Over time, oxidation can severely degrade the mechanical properties of conventional UHMWPE, which, in conduction with other surgical factors, can lead to both accelerated wear debris production and bone loss, and/or component fatigue cracking/fracture, all leading to corrective revision surgery.”

The recalled ankle and knee implants have been used in the following knee and ankle systems manufactured by Exactech:

  • Optetrak (Partial Knee Replacement Systems)
  • Optetrak (Total Knee Replacement Systems)
  • Truliant (Total Knee Replacement Systems)
  • Vantage (Total Ankle Replacement Systems)

We Want To Hear Your Story

Zimmerman Reed has successfully represented clients in some of the largest defective hip and knee replacements cases. If you were implanted with an Exactech knee or ankle replacement device since 2004, we’d like to hear from you. We are accepting Exactech knee and ankle implant cases, and our experienced attorneys and professionals are ready to talk about your specific situation and discuss your options. Start by either completing the short questionnaire or you can call us at 800.755.0098.

Your Team

jason johnston
Jason Johnston | Partner

View Full Bio
barb doten
Barb Doten | Client Liaison

View Full Bio
jennifer sustacek
Jennifer Sustacek | Attorney

View Full Bio
jennifer galzki
Jennifer Galzki | Paralegal

View Full Bio
melissa krause
Melissa Krause | Medical Record Specialist

View Full Bio