EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Summary
The FDA issued a Class II for EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base by MicroPort Orthopedics Inc.. Reason: One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL .
Details
Source
Device Recall
External ID
Z-0275-2023
Action Date
2023-02-22
Status
Ongoing
Category
device
Product Description
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Lot/Code Info: UDI/DI 0 0192629 08287 8, Lot 1916559
Quantity Affected: 24 units
Reason for Recall
One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
Distribution
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-28
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 157 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-0275-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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