EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only
Summary
The FDA issued a Class II for EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replac by MicroPort Orthopedics Inc.. Reason: One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery a.
Details
Source
Device Recall
External ID
Z-2244-2024
Action Date
2024-07-10
Status
Ongoing
Category
device
Product Description
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Lot/Code Info: UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR
Quantity Affected: 40 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.
Distribution
International distribution in the country of China. There is no field inventory in the United States for either lot.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-03
Company
Arlington, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MicroPort Orthopedics Inc. has 17 FDA actions in our database, including 6 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MicroPort Orthopedics Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MicroPort Orthopedics Inc. have FDA actions?
MicroPort Orthopedics Inc. has 17 FDA actions in our database, including 6 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2244-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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