Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Summary
The FDA issued a Class II for Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to pos by INCIPIO DEVICES. Reason: Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld..
Details
Source
Device Recall
External ID
Z-0549-2025
Action Date
2024-12-04
Status
Ongoing
Category
device
Product Description
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Lot/Code Info: Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Quantity Affected: 100 units
Reason for Recall
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Distribution
US Nationwide distribution in the state of TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-30
Company
St-Blaise
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 162 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 (INCIPIO DEVICES) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INCIPIO DEVICES have FDA actions?
This is the only FDA action we have on record for INCIPIO DEVICES in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0549-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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