Orthopedic Surgical Instrument Kit Recalled for Improper Driver Fit
The Nextra Hammertoe Correction System surgical kit is being recalled due to an oversized driver that cannot properly connect to and remove from the implant. This defect can delay surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a functional defect that poses a risk of harm during surgical procedures. No injuries or complications have been reported, classifying it as a risk-of-harm product where injury has not yet materialized.
Plain-English summary
Nextremity Solutions is recalling the Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit (SKU: NX-4532K), an orthopedic surgical instrument used in hammertoe correction procedures. The recall affects devices with lot numbers 168117318B and 168125017C, distributed nationwide in the United States, Japan, and the Netherlands.
The proximal end of the driver component is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant. This defect causes delays in surgical procedures.
Physicians and facilities using this kit should discontinue use and contact Nextremity Solutions for replacement or further instructions.
The recalled product
- Product
- Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
- Manufacturer
- Nextremity Solutions
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 168117318B
- 168125017C UDI: 00817701020011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Nextremity Solutions under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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See all →- HighHammertoe Correction Surgical System Recalled for Driver Connection Defect
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