DJO EMPOWR KNEE Femoral Sizer
Recall
- Recall Number
- Z-1524-2021
- Event Number
- 87332
- FEI Number
- 1000116912
- Product Code
- JWH
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 5, 2021
- Address
- 9800 Metric Blvd, Encore Medical, LP, Austin, TX, 78758-5445
Description
DJO EMPOWR KNEE Femoral Sizer
Incorrect assembly of a subcomponent by a vendor and as a result, the windows provided to show the size are facing the opposite direction.
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 [email protected]
U.S.: FL, IN, and MN O.U.S.: None
16 units