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

Medical DevicesSource: FDA (device) · Date: 2026-02-11

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Encore Medical, LP
Product
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
Recall initiated
2026-01-05
Code info
UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Product quantity
19
Voluntary mandated
Voluntary: Firm initiated
City
Austin
State
TX
Country
United States
Event id
98177
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