Femoral Knee Prosthesis Components May Have Incorrect Packaging
MicroPort Orthopedics recalls EVOLUTION MP femoral knee prosthesis components due to incorrect packaging. The devices are correctly marked internally but may have wrong labels on their packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II with no reported illnesses or injuries. The issue is incorrect packaging labels only, with devices correctly marked internally. Packaging-only issues in surgical device context warrant Moderate severity due to identification concerns, but lack reported harm for higher severity.
Plain-English summary
MicroPort Orthopedics Inc. is recalling EVOLUTION MP femoral knee prosthesis components due to packaging defects. The affected components are Size 5 right primary porous (reference EFSRP5PR) and Size 6 left primary non-porous (reference EFSRN6PL). The devices themselves have correct markings, but the packaging labels may be incorrect.
Thirty-two units were affected and distributed outside the United States to China, Greece, Spain, South Africa, France, Japan, and Italy. This is an FDA Class II medical device recall.
The recalled product
- Product
- 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
- Manufacturer
- MicroPort Orthopedics Inc.
- Hazard
- Affected units
- 32
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · MicroPort Orthopedics Inc.
See all →- ModerateReusable hip trial components recalled over missing FDA premarket authorization
FDA (Devices) · 2026-01-28
- HighMicroPort Knee Implant Recall: Wrong Size Component in Packaging
FDA (Devices) · 2024-07-10
- HighMicroPort Recalls Evolution MP Tibial Bases Due to Wrong Size in Packaging
FDA (Devices) · 2023-02-22
- HighEVOLUTION MP Tibial Base knee component recalled for wrong product in packaging
FDA (Devices) · 2023-02-22
- HighHip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot
FDA (Devices) · 2022-06-08
Same hazard · incorrect packaging
See all →- ModerateHenry Schein Recalls Dental Composite Capsules Due to Incorrect Packaging
FDA (Devices) · 2026-09-02
- HighBone fixation plates recalled due to product packaging mix-up
FDA (Devices) · 2023-03-08
- HighInvisalign Orthodontic Aligners Recalled for Software Defect Causing Incorrect Quantities
FDA (Devices) · 2023-02-01
- ModerateColtene Whaledent FG 57 Dental Burs Recalled for Packaging Error
FDA (Devices) · 2020-11-25
- ModerateStrauss 25 Carbide Dental Burs Recalled for Incorrect Packaging
FDA (Devices) · 2020-11-25