Salt Lake City, UT, United States
Total Joint Orthopedics, Inc. recalls
1 recall recorded since 2018, most recently on 23 September 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 September 2025
- Reason
- Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- Distribution
- US Nationwide distribution in the states of Ohio, Texas, Florida, Georgia, and North Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0432-2026
- Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.