Summary
The FDA issued a Class II for HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144 by Mizuho OSI. Reason: One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number..
Details
Source
Device Recall
External ID
Z-1573-2022
Action Date
2022-08-31
Status
Ongoing
Category
device
Product Description
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Lot/Code Info: Model Number: 6850-144 UDI Code: (01)00842430106842(10)MIZ210712(11)210712 Lot/Batch Number: MIZ210712
Quantity Affected: 13 devices
Reason for Recall
One batch of "regular" femoral hooks were incorrectly etched with the "classic" femoral hook model number.
Distribution
U.S Nationwide Distribution .: CA, FL, GA, MI, NE, NJ, TN, UT, and WA O.U.S.: Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-29
Company
Union City, CA
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 194 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 (Mizuho OSI) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mizuho OSI have FDA actions?
This is the only FDA action we have on record for Mizuho OSI in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1573-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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