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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
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