MicroPort Knee Implant Recall: Wrong Size Component in Packaging
MicroPort's EVOLUTION MP knee implants recalled due to one confirmed case where a Size 3 left-side component was packaged in a Size 4 right-side box. No injuries reported; distribution is limited to China with no U.S. inventory.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device with critical packaging error placing wrong size and orientation components in packages, creating surgical risk. No reported illnesses or injuries limit it to High severity per the rubric's risk-of-harm criterion.
Plain-English summary
MicroPort Orthopedics Inc. is recalling EVOLUTION™ MP Femoral CS/CR Non-Porous total knee replacement implants due to a packaging and component substitution error. One confirmed incident involved Size 4 right-side components (part number EFSRN4PR, lot MP1982170) that were opened during surgery and found to contain Size 3 left-side components (part number EFSRN3PL, lot MP1982097) instead.
A size and orientation mismatch between packaged and actual contents creates a critical surgical risk. If an unaware surgeon proceeded with implantation without verification, the mismatched implant could cause surgical complications or failure of the knee replacement.
The recalled units were distributed internationally to China only, with no field inventory in the United States.
No illnesses or injuries have been reported to date.
The recalled product
- Product
- EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
- Manufacturer
- MicroPort Orthopedics Inc.
- Affected units
- 40
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1
- Part EFSRN4PR: Primary DI Number M684EFSRN4PR1
- lot Number's: MP1982097
- MP1982170
- Catalog Number(s): EFSRN3PL
- EFSRN4PR
Distribution
Distribution scope not specified by the agency.
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