Agency classClass IIOur severity:High FDA (Devices)·Z-0740-2022·Announced 2022-03-16

Surgical hammertoe instruments recalled for potential locking mechanism deformation

The Nextra Cannulated Hammertoe Standard Instrument Kit's driver may deform the implant locking mechanism during insertion, potentially requiring revision 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 recall of a surgical implant instrument kit where the driver may deform the locking mechanism during insertion, potentially resulting in the need for revision surgery. The source describes the potential harm mechanism without reporting actual injuries or adverse events.

Plain-English summary

Nextremity Solutions has recalled the Nextra Cannulated Hammertoe Standard Instrument Kit (SKU: CH-STD-KT), a surgical instrument set designed for small bone reconstruction, specifically for inter-digital repair and fusion of the lesser toe. The recall affects 24 units with lot numbers 1574701 and 158961.

During insertion of the middle phalanx implant into bone, the driver tool may deform the implant's locking mechanism. This deformation results in inadequate mating force between the middle and proximal phalanx implants, which may compromise the surgical repair.

If the locking mechanism deforms, surgeons may experience surgical delay, need to remove the implant in-situ, require an alternative surgical approach, need to disassemble the implants post-operatively, or need to perform revision surgery. Healthcare facilities and surgeons with affected lot numbers should discontinue use and contact Nextremity Solutions.

The recalled product

Product: Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe SKU: CH-STD-KT
Manufacturer: Nextremity Solutions
Category: Medical Device — Orthopedic surgical instruments
Hazard: implant-deformation
inadequate-fixation
surgical-complication
Affected units: 24

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 Numbers: 1574701
158961 UDI: 00817701026372

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 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 2 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 driver oversized, affecting hammertoe correction
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

Same hazard · implant deformation