RegWardenFDA facility compliance records
Recall

Class II — MicroPort Orthopedics Inc.

Recalling firmMicroPort Orthopedics Inc.
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonOne 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.
ProductEVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Quantity24 units
DistributionInternational Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Initiated2022-10-28
Classified2022-11-22
Terminated2026-09-10
Recall numberZ-0275-2023
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — MicroPort Orthopedics Inc. (Z-0275-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91102/

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