Knee Tibial Insert Recalled Due to Component Mix-Up in Packaging
Encore Medical is recalling the EMPOWR 3D Knee Tibial Insert due to a packaging error where hip and knee components were swapped, potentially causing surgeons to use the wrong implant during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no reported illnesses or injuries. The hazard is a risk-of-harm situation where surgeons could receive incorrect surgical components, but injury has not yet been reported, placing this at the maximum score for theoretical risks without reported harm.
Plain-English summary
Encore Medical, LP is recalling the EMPOWR 3D Knee Tibial Insert, model 5R, 10MM, VE (Reference: 342-10-705) due to a packaging error. Within the inner pack, knee insert and hip acetabular system components were swapped prior to the tray being sealed.
This error could result in surgeons not having the correct component for knee surgery. Because hip and knee implants have different anatomical designs, implanting an incorrect component during surgery could compromise the surgical outcome.
The recall affects 36 units with Lot 075T1167 (Expiration: March 30, 2028) that were distributed to medical facilities in Florida, California, Indiana, Hawaii, Louisiana, Minnesota, Arizona, Texas, New Jersey, Pennsylvania, Kansas, Tennessee, Puerto Rico, South Carolina, and Washington.
Healthcare providers who received this product should immediately cease use and contact Encore Medical for replacement units.
The recalled product
- Product
- EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705
- Manufacturer
- Encore Medical, LP
- Affected units
- 36
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI-DI: 00888912167321
- Lot: 075T1167
- Expiration: March 30
- 2028
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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