Klassic BiPolar Head recall — FDA event 97708

What the official notice recommends

1. On September 5, 2025 Total Joint issued customer a Field action notification. On September 23, 2025, Total Joint issued a Urgent Medical Device Recall Notification. Total Joint ask consignees to take the following actions:
2. 1. Stop implanting the affected product.
3. 2. Locate and quarantine all affected inventory.
4. 3. With preliminary info we initially sent a Market Withdrawal notification on 9/05/2025 to initiate the quarantining and return of all BiPolar Heads in your possession.
5. 4. A list of all BiPolar Heads in your possession as of 9/05/2025 is shown within the letter, if you have already returned them we appreciate your swift response, if not please return these items immediately.
6. 5. Please complete and return the attached acknowledgment form confirming receipt of this notice and detailing the quantities returned. If inventory discrepancies are identified, please note that in the Return Response Box.
7. 6. Please contact Total Joint Orthopedics at (801)486-6070 with any questions or concerns.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.