FDA recall Z-1233-2026

Product

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.

Distribution

US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Key facts

Status

Ongoing

Initiation date

2026-01-05

Report date

2026-02-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Austin, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2026