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.
What this means for you
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
- Hazard
- manufacturing-defect
- surgical-instrument-malfunction
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.
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