Orthopedic knee implant component lacks final sterilization before shipment
Encore Medical recalls 20 DJO Surgical Empowr Knee tibia baseplate components that were not sterilized before shipment. If implanted, these components may cause infection requiring treatment or revision 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: This is a Class II medical device recall for a surgical implant component that was not sterilized, creating a significant risk of post-surgical infection. No illnesses or injuries have been reported, making this a theoretical risk-of-harm scenario.
Plain-English summary
Encore Medical, LP is recalling 20 DJO Surgical Empowr Knee, Universal Tibia Baseplate (Model 6R, REF 352-02-106) units due to a manufacturing defect.
The recalled components were not subjected to final sterilization before shipment. Implantation of non-sterile orthopedic components creates a risk of post-surgical infection.
This recall affects units distributed across the United States (including Puerto Rico), Sweden, Australia, France, United Kingdom, Colombia, and Germany. The affected lot number is 308V1112, expiring May 25, 2029.
If you have received or used one of these implant components, contact Encore Medical immediately. Do not implant additional units from this lot. Consult with your healthcare provider if you have concerns about a component you may have already received.
The recalled product
- Product
- DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
- Manufacturer
- Encore Medical, LP
- Affected units
- 20
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 (2)
- UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25
- 2029
Distribution
Part of a larger recall action
This product is one of 5 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.
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