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Open, Classified

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

FDA Recall Z-2244-2024 · Posted 2024-07-01

Recalling FirmMicroPort Orthopedics Inc.
Recall StatusOpen, Classified
Product CodeHRY
Date Initiated2024-05-03
Product Quantity40 units

Reason for Recall

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.

Firm Action

The recalling firm issued the FSN, dated 05/02/2024, via email. The required actions were to: Immediately check inventory and quarantine all subject product(s); COMPLETE AND RETURN the attached FSCA Acknowledgement; Inform MicroPort Orthopedics of any adverse event immediately; Return any affected product to: MicroPort Orthopedics Inc. 1481 Gulf Stream, Arlington, TN 38002. The consignee is to mark all return shipping boxes with RECALL on several sides for better identification and processing.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102380EVOLUTION MP TOTAL KNEE SYSTEMWrightmedicaltechnologyinc · 2011-01-07K093552EVOLUTION MP TOTAL KNEE SYSTEMWrightmedicaltechnologyinc · 2010-03-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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