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Recall Observatory FDA recall evidence

Device product

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

Z-0626-2024

October 05, 2023

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 93623
Status
Completed
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0626-2024

Official wording

Reason: Mislabeling

Code information: UDI: (01)00888912108560/Lot Number(s): 157N1556

Distribution pattern: US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeling