EMPOWR 3D Knee Tibial Insert Package Mix-Up Causes Surgical Delays
Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a packaging mix-up where orthopedic implants of different sizes may be placed in incorrect packages. While no illnesses or injuries have been reported, this qualifies as a risk-of-harm product without reported injury, meeting the criteria for High (3) severity under the rubric.
Plain-English summary
Encore Medical, LP is recalling EMPOWR 3D Knee Tibial Insert packages due to a packaging error in which packages may contain the wrong size implant. Specifically, packages labeled as 5R 16MM (REF: 342-16-705) may contain 3R 14MM models (REF: 342-14-703), and vice versa.
This mix-up could delay scheduled orthopedic surgeries. A surgeon discovering the wrong size implant in an opened package would be unable to proceed and would need to obtain the correct size.
The recall affects 33 units distributed nationwide to healthcare facilities in Virginia, Minnesota, Texas, Wisconsin, Iowa, Illinois, Indiana, South Carolina, New York, Maryland, California, Florida, Arizona, and Washington. The affected units can be identified by their lot numbers: Lot 159T1086 for the 5R 16MM model and Lot 137T1086 for the 3R 14MM model.
Healthcare facilities and surgeons should verify that received EMPOWR 3D Knee Tibial Insert packages contain the correct size before opening.
The recalled product
- Product
- EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
- Manufacturer
- Encore Medical, LP
- Hazard
- product-mix-up
Distribution
Distributed nationwide across the United States.
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