Orthopedic surgical driver oversized, affecting hammertoe correction
Nextremity Solutions is recalling the Nextra Hammertoe Correction System Driver (SKU: NX-DR) due to oversizing at the proximal end, which impairs connection and removal from the implant, causing surgical delays. The defect affects 239 units distributed in the US, Japan, and the Netherlands.
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: This is a surgical instrument (risk-of-harm product) with a documented manufacturing defect that directly affects device function during surgery. No injuries or illnesses have been reported, but the oversizing defect creates operational risk during an invasive procedure.
Plain-English summary
Nextremity Solutions is recalling 239 units of the Nextra Hammertoe Correction System Driver (SKU: NX-DR, Lot 168A27917C, UDI: 00817701020837) due to a manufacturing defect affecting the proximal end of the driver.
The proximal end is oversized in varying degrees, making the driver difficult to properly connect with and remove from the proximal Nextra implant during hammertoe correction surgery. This causes delays in surgical procedures. No injuries, illnesses, or hospitalizations have been reported in connection with this defect.
The affected devices were distributed nationwide in the United States, as well as in Japan and the Netherlands. Orthopedic surgeons using this system should inspect devices from lot 168A27917C for proper fit and function before use. If connection or removal difficulties are encountered, contact Nextremity Solutions immediately.
The recalled product
- Product
- Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
- Manufacturer
- Nextremity Solutions
- Affected units
- 239
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: 168A27917C UDI: 00817701020837
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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