The Recall Desk

Manufacturer

Nextremity Solutions

15 recalls in our database name Nextremity Solutions as the manufacturing or recalling firm.

What the numbers show

Total
15
Critical
0
Severe
0
Most recent
2022-04-20

Of the 15 recalls from Nextremity Solutions we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

  • HighFDA (Devices)·Z-0910-2022·2022-04-20

    Orthopedic Surgical Instrument Kit Recalled for Improper Driver Fit

    The Nextra Hammertoe Correction System surgical kit is being recalled due to an oversized driver that cannot properly connect to and remove from the implant. This defect can delay surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2022·2022-04-20

    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.

    Product
    Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2022·2022-04-20

    Orthopedic surgical hammertoe instrument recalled for improper component sizing

    Nextremity Solutions is recalling the Nextra Hammertoe Correction System due to an oversized driver component that makes it difficult to properly connect and remove during surgery.

    Product
    Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2022·2022-04-20

    Nextra Hammertoe Correction System surgical instruments recalled for defective connector

    Nextremity Solutions recalls 459 units of the Nextra Hammertoe Correction System due to an oversized proximal driver end that prevents proper connection and removal during surgery.

    Product
    Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2022·2022-04-20

    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.

    Product
    Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0740-2022·2022-03-16

    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.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0739-2022·2022-03-16

    Nextra CH Hammertoe Surgical Implant Kit Recalled for Locking Mechanism Defect

    Nextremity Solutions recalls the Nextra CH Hammertoe Mini Instrument Kit for a defect that may deform the implant's locking mechanism during insertion, potentially requiring revision surgery.

    Product
    Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1501-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 123 units of InCore Lapidus Disposable Kits because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-1500-2021·2021-05-05

    Nextremity Solutions Recalls InCore Lapidus Disposable Kits Due to Drill Bushing Defect

    Nextremity Solutions is recalling 111 units of the InCore Lapidus Disposable Kit 28mm Left because a drill bushing defect may prevent surgeons from completing the intended procedure.

    Product
    InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1458-2020·2020-03-18

    Nextremity Solutions Recalls Nextra Hammertoe Correction System Due to Driver Defect

    Nextremity Solutions is recalling 190 units of the Nextra Hammertoe Correction System because the driver may be oversized, making it difficult to remove from the implant.

    Product
    Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1127-2020·2020-02-19

    Nextremity Solutions Recalls Stratum Lapidus Plate Due to Labeling Error

    Nextremity Solutions is recalling 40 Stratum Lapidus Plate units because the package labeling indicates a right plate, but the product contains a left plate.

    Product
    Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0777-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 86 Stratum MDS Screws because the components are 2mm shorter than indicated on the package label.

    Product
    Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0776-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 87 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.

    Product
    Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0778-2020·2020-01-15

    Nextremity Solutions Recalls Stratum MDS Screws Due to Length Discrepancy

    Nextremity Solutions is recalling 86 Stratum MDS Screws because they are 2mm shorter than the length indicated on the package label.

    Product
    Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0534-2020·2019-12-04

    Nextremity Solutions Recalls Stratum Foot Plating System Screws Due to Incorrect Specifications

    Nextremity Solutions is recalling 49 units of Stratum Foot Plating System screws because they may contain the incorrect screw type and length.

    Product
    Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and sma
    Category
    Medical Device
    Distribution
    Distributed nationwide