FDA Device recall Z-2603-2023
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
- FDA Device
- Class II
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 by Encore Medical, citing orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, p….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2603-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-04 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Encore Medical |
| Distribution | AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA |
Product
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Reason
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery
Identifiers
| code_info | UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2603-2023%22
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