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Recall Observatory FDA recall evidence

Device product

EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703

Z-0766-2025

December 18, 2024

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 96019
Status
Ongoing
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-0766-2025

Official wording

Reason: 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.

Code information: REF/UDI-DI/Lot: 342-16-705/00888912167628/159T1086 342-14-703/00888912167505/137T1086

Distribution pattern: US Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC, NY, MD, CA, FL, AZ, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.