EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Reported: January 1, 2025 Initiated: December 18, 2024 #Z-0766-2025
Product Description
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
Reason for Recall
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 33
- Distribution
- US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703. Recalled by Encore Medical, LP. Units affected: 33.
Why was this product recalled? ▼
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2025. Severity: Moderate. Recall number: Z-0766-2025.
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