Agency classClass IIOur severity:High FDA (Devices)·Z-0914-2022·Announced 2022-04-20

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.

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 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
Category: Medical Device — Orthopedic surgical instrument
Hazard: manufacturing-defect
connection-defect
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 →

Same manufacturer · Nextremity Solutions

See all →

High
Orthopedic Surgical Instrument Kit Recalled for Improper Driver Fit
FDA (Devices) · 2022-04-20
High
Orthopedic surgical hammertoe instrument recalled for improper component sizing
FDA (Devices) · 2022-04-20
High
Nextra Hammertoe Correction System surgical instruments recalled for defective connector
FDA (Devices) · 2022-04-20
High
Hammertoe Correction Surgical System Recalled for Driver Connection Defect
FDA (Devices) · 2022-04-20
High
Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect
FDA (Devices) · 2022-03-16

Same hazard · manufacturing defect