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Recall Observatory FDA recall evidence

Device product

EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.

Z-2244-2024

May 03, 2024

Class II

Product summary

Firm
MicroPort Orthopedics Inc.
Event
Event 94729
Status
Ongoing
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-2244-2024

Official wording

Reason: One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.

Code information: UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR

Distribution pattern: International distribution in the country of China. There is no field inventory in the United States for either lot.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.