Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Summary
The FDA issued a Class II for Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K by Nextremity Solutions. Reason: Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, cau.
Details
Source
Device Recall
External ID
Z-0910-2022
Action Date
2022-04-20
Status
Terminated
Category
device
Product Description
Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
Lot/Code Info: Lot Number: 168117318B, 168125017C UDI: 00817701020011
Quantity Affected: 4 units
Reason for Recall
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Distribution
Distribution US Nationwide, Japan, and the Netherlands
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-10
Company
Warsaw, IN
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 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Nextremity Solutions has 7 FDA actions in our database, including 7 recalls.
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 (Nextremity Solutions) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Nextremity Solutions have FDA actions?
Nextremity Solutions has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0910-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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