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Recall Observatory FDA recall evidence

Device product

EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

Z-0275-2023

October 28, 2022

Class II

Product summary

Firm
MicroPort Orthopedics Inc.
Event
Event 91102
Status
Ongoing
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-0275-2023

Official wording

Reason: One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

Code information: UDI/DI 0 0192629 08287 8, Lot 1916559

Distribution pattern: International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.