Z-2104-2021 Class II Ongoing
FDA device recall Z-2104-2021 was initiated by Encore Medical, LP on May 12, 2021 and is designated Class II. Reason for recall: Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis. The recall status is ongoing. Affected quantity: 10 units.
Recall details
- Product Type
- Devices
- Report Date
- Jul 28, 2021
- Initiation Date
- May 12, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product description
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. 11 16mm, CE 0086, Sterile H2O2, UDI: (01)00888912167185
Reason for recall
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Distribution pattern
US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
Code information
Lot # 155T1035
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2104-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026