Hammertoe Correction Surgical System Recalled for Driver Connection Defect
Nextremity Solutions recalls the Nextra Hammertoe Correction System because the driver's proximal end is oversized, making it difficult to connect and remove from the implant, potentially delaying 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: FDA Class II medical device with manufacturing defect affecting surgical instrument functionality. While no reported injuries or hospitalizations exist, the oversized driver component prevents proper connection and removal, creating operational risk during surgical procedures.
Plain-English summary
Nextremity Solutions is recalling the Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut (SKU: NX-3532K-SC), an orthopedic surgical instrument used in hammertoe correction procedures. The recall involves 89 units distributed nationwide in the United States, as well as in Japan and the Netherlands.
The proximal end of the driver component is oversized in varying degrees. This manufacturing defect makes it difficult to fully connect with and remove from the proximal Nextra implant, potentially causing delays during surgical procedures.
Healthcare facilities and surgeons should immediately discontinue use of the affected lot (Lot Number: 168125017B, UDI: 00817701020059) and contact Nextremity Solutions for replacement units or additional instructions. Any adverse events related to use of this device should be reported to the FDA.
The recalled product
- Product
- Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
- Manufacturer
- Nextremity Solutions
- Affected units
- 89
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 (1)
- Lot Number: 168125017B UDI: 00817701020059
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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