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Recall Observatory FDA recall evidence

Device product

EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705

Z-0102-2024

August 22, 2023

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 93098
Status
Ongoing
Classification
Class II
Quantity
36
Official record key
device-enforcement:Z-0102-2024

Official wording

Reason: Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Code information: UDI-DI: 00888912167321, Lot: 075T1167, Expiration: March 30, 2028

Distribution pattern: US Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX, NJ, PA, KS, TN, PR, SC, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).