In August 2021, Exactech, an orthopedic implant manufacturer, recalled its knee, hip, and ankle replacement devices after discovering that about 80% of polyethylene inserts produced since 2004 were packaged in non-conforming vacuum bags. In April 2022, the recall was expanded to nearly 180,000 polyethylene inserts used in orthopedic joint replacements.

The recall stemmed from packaging issues that allowed oxygen exposure, leading to premature oxidation and degradation of the plastic inserts before implantation. This degradation accelerated wear and damage to the implants, causing accelerated debris, osteolysis, instability, joint swelling and often necessitating revision surgeries within just a few years.

Recall: In June 2021 Exactech announced a recall of 40,000 of its hip models due to excessive premature wear of the liner. By 2024 it had recalled more than 650,000 devices due to the improper packaging.

Bankruptcy: On October 29, 2024, Exactech announced it was filing for Chapter 11 Bankruptcy, while indicating that it is being purchased by a group of private equity companies led by TPG.

FDA Recall

In June 2021 Exactech announced a recall of 40,000 of its hip models due to excessive premature wear of the liner. By 2024 it had recalled more than 650,000 devices due to the improper packaging.

Bankruptcy

On October 29, 2024, Exactech announced it was filing for Chapter 11 Bankruptcy, while indicating that it is being purchased by a group of private equity companies led by TPG.

MDL

MDL #3044: Eastern District of New York, Judge Nicholas G. Garaufis

Litigation Updates

October 2024 Exactech files for Chapter 11 bankruptcy protection. This resulted in a complete stay in all MDL and Florida state-coordinated proceedings. In a genius move, plaintiffs MDL leadership showed up at the bankruptcy hearing and helped get 7 of the 9 Bankruptcy Creditor Committee appointments filled with injured plaintiffs. The bankruptcy also opened up private equity firm, and postulated suitor to acquire Exactech, for discovery. ALL CLAIM FORMS MUST BE FILED BY FEBRUARY 7, 2025!

Important Links

1. https://www.fda.gov/medical-devices/safety-communications/risks-exactech-joint-replacement-devices-defective-packaging-fda-safety-communication
2. https://www.reuters.com/legal/litigation/medical-implant-maker-exactech-files-bankruptcy-after-recall-litigation-2024-10-29/
3. https://www.exac.com/recall-information/

MDL Link

1. https://www.govinfo.gov/app/details/USCOURTS-nyed-1_22-md-03044/summary

Case Management Orders

• CMO 1
• CMO 2
• CMO 2 (Amended)
• CMO 3
• CMO 3 (Amended)
• CMO 4 
• CMO 5

Bellwether Case Management Orders

1. BW CMO 2
2. BW CMO 3

Discovery Orders

• CMO Governing Master Discovery
• CMO Governing Master Discovery (Amended)
• ESI
• Protective

Plaintiff Fact Sheet Orders

• PFS Implementation 
• PFS Implementation (Amended)

Practice & Procedure Orders

• PPO 1
• PPO 2
• PPO 2 (Amended)
• PPO 3
• PPO 4
• PPO 5