TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Pro
Summary
The FDA issued a Class II for TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409- by Grace Medical, Inc.. Reason: Due to incorrect functional length on device labeling..
Details
Source
Device Recall
External ID
Z-2308-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis
Lot/Code Info: Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927
Quantity Affected: 7
Reason for Recall
Due to incorrect functional length on device labeling.
Distribution
U.S Nationwide distribution in the state of MD.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-03
Company
Bartlett, 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 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Grace Medical, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 (Grace Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Grace Medical, Inc. have FDA actions?
Grace Medical, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2308-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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