Summary
The FDA issued a Class II for PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK by MicroPort Orthopedics Inc.. Reason: One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body..
Details
Source
Device Recall
External ID
Z-1225-2022
Action Date
2022-06-08
Status
Terminated
Category
device
Product Description
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Lot/Code Info: Catalog Number(s): PHAPCLS7; Lot Number(s): 1903727; Expiration Date: 11/24/2029; UDI/DI Number: 00192629112773
Quantity Affected: 8 units
Reason for Recall
One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-04
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 184 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-1225-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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