DJO EMPOWR KNEE Femoral Sizer Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DJO EMPOWR KNEE Femoral Sizer
Lot Codes / Batch Numbers
Model Number: 800-05-034 Lot Number: 326336L02
Products Sold
Model Number: 800-05-034 Lot Number: 326336L02
A medical device manufacturer is recalling DJO EMPOWR KNEE Femoral Sizer due to Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
Recommended Action
Per FDA guidance
On 02/05/2021, the firm sent an "URGENT FIELD SAFETY NOTICE" Recall letter to customers via e-mail informing them that a product complaint was received where a subcomponent of the sizer was assembled incorrectly. As a result, the windows provided to show the size are facing the opposite direction. When the sizer is in place, the size read from the distal facing side of the instrument is obscured. The risks associated with this issue include: -Delay in surgery -Revision surgery Customers are instructed to the below actions by February 26, 2021: 1. This notice needs to be passed on to all those within their organization or to any organization where the potentially affected product has been transferred. 2. Review their stock for the affected products and lot numbers and to quarantine the items until returned. 3. Contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. Customers will be provided with a shipping label to return the affected product. 4. Return all affected devices (quantities listed above) using the RMA number. Any questions or assistance - contact the Manager, Regulatory Affairs at e-mail teffany.hutto@djoglobal.com
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 noticeDistribution
As reported by FDA
FL, IN, MN
Page updated: Jan 10, 2026