Z-2603-2023 Class II Ongoing
FDA device recall Z-2603-2023 was initiated by Encore Medical, LP on Aug 4, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 20.
Recall details
- Product Type
- Devices
- Report Date
- Sep 27, 2023
- Initiation Date
- Aug 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product description
DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Reason for recall
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
Distribution pattern
US: 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. OUS: Sweden, Australia, France, UK, Colombia, Germany
Code information
UDI-DI/Lot/Expiration: 00190446258032/308V1112/May 25, 2029
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2603-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026