Skip to content
Recall Observatory FDA recall evidence

Device product

EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Z-1233-2026

January 05, 2026

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 98177
Status
Ongoing
Classification
Class II
Quantity
19
Official record key
device-enforcement:Z-1233-2026

Official wording

Reason: 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.

Code information: UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.