DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
Reported: July 28, 2021 Initiated: May 12, 2021 #Z-2103-2021
Product Description
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980
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.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 10 units
- Distribution
- US: Nationwide Distribution in the states of VA, MN, TX, IL, MS, CA, KS, LA, and GA OUS: None
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980. Recalled by Encore Medical, LP. Units affected: 10 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2103-2021.
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