EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Reported: February 11, 2026 Initiated: January 5, 2026 #Z-1233-2026
Product Description
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Reason for Recall
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Details
- Recalling Firm
- Encore Medical, LP
- Units Affected
- 19
- Distribution
- US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705. Recalled by Encore Medical, LP. Units affected: 19.
Why was this product recalled? ▼
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1233-2026.
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