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Open, Classified

EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component

FDA Recall Z-0699-2025 · Posted 2024-12-18

Recalling FirmMicroPort Orthopedics Inc.
Recall StatusOpen, Classified
Product CodeMBH
Date Initiated2024-10-29
Product Quantity32

Reason for Recall

Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.

Firm Action

On 10/29/24 field safety notices were emailed to customers who were asked to do the following: 1) Check inventory and quarantine all subject product(s) 2) Return affected products 3) Complete and return the acknowledgement form via email to [email protected] For questions or additional information please contact the firm at: +31 20 545 01 00, or [email protected]

Root Cause

Labeling Change Control

Distribution Pattern

OUS: CN, GR, ES, ZA, FR, JP, IT

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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