DJO EMPOWR 3D Knee (Unknown) – Mispackaged Insert (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
Lot Codes / Batch Numbers
Lot number 078T1141
Products Sold
Lot number 078T1141
A medical device manufacturer is recalling DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 due to A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving deb. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
Recommended Action
Per FDA guidance
On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions: 1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred. 2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices. 3) Customers with questions or issues can contact Customer Service.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026