The Recall Desk

Hazard

Fracture recalls

160 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
160
Critical
4
Severe
83
Most recent
2026-07-29

Of the 160 fracture recalls we have scored against our rubric, 4 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 83 (52%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all fracture recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

26–50 of 160

  • SevereFDA (Devices)·Z-2577-2021·2021-10-06

    Reperfusion Catheter Recalled Due to Risk of Distal End Fracture

    Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.

    Product
    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2021·2021-09-29

    Phantom Nail System surgical drill recalled for fracture risk

    Paragon 28 is recalling Phantom Nail System surgical drills due to a thin wall condition between the cannulation and flutes. This defect could potentially cause the drill to fracture during use.

    Product
    Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2402-2021·2021-09-15

    Pipeline Flex Embolization Device Recalled for Potential Push Wire Fracture Risk

    Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.

    Product
    Pipeline Flex Embolization Device
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-1379-2021·2021-04-14

    Howmedica Recalls Specialty Triathlon TS Trial Cutting Guides Due to Fracture Risk

    Howmedica Osteonics Corp. is recalling Specialty Triathlon TS Trial Cutting Guides because the posterior condyle may fracture during transport or surgery.

    Product
    Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer. Catalog Number: I-K3834CG00 Specialty Triathlon TS Trial Cutting Guide Set I-
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1367-2021·2021-04-14

    Terumo Sternal Retractor Locking Mechanism Recall for Fracture Risk

    Terumo is recalling 12 sternal retractor devices because the stainless steel locking plates may fracture. The devices were distributed in eight US states.

    Product
    Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0612-2020·2021-02-03

    Enztec Femoral Impactor Recall Due to Arm Fracture Risk

    Enztec Limited is recalling 312 femoral impactors used with the DJO EMPOWR 3D KNEE system because the arm may fracture during use, potentially causing surgical delays or inflammatory responses.

    Product
    REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0696-2021·2020-12-30

    Zimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk

    Zimmer Biomet is recalling 4,713 Spinal Rod Cutters because they may fracture during use. The devices were distributed domestically and internationally.

    Product
    Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·20V726000·2020-11-20

    2021 Lincoln Aviator steering knuckle defect increases crash risk

    Ford is recalling certain 2021 Lincoln Aviator vehicles due to improperly manufactured steering knuckles that may fracture, reducing steering control and increasing crash risk. Dealers will inspect and replace affected knuckles free of charge.

    Product
    LINCOLN — LINCOLN AVIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2742-2020·2020-08-05

    OrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk

    OrthoPediatrics Corp is recalling 73 units of 6.0MM spine rods because incorrect laser etching may compromise strength and lead to unintended fracture.

    Product
    Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc d
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2020·2020-03-04

    Zimmer Biomet Recalls THP Hip Plating System Due to Fracture Risk

    Zimmer Biomet is recalling 1,662 units of the THP Hip Plating System after internal testing detected a potential increase in fracture rate and packaging discoloration.

    Product
    THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-0168-2020·2019-10-30

    Exactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk

    Exactech, Inc. is recalling 158 Ergo 3.2mm K-wires because they may fracture at the threads and remain in the glenoid during shoulder surgery.

    Product
    Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2019·2019-05-15

    Zimmer Biomet Recalls T7 Driver Solid AO Due to Fracture Risk

    Zimmer Biomet is recalling 1,924 T7 Driver Solid AO units because they may fracture, bend, or shear during use.

    Product
    T7 Driver Solid AO (Part Number 110018541) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalang
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2019·2019-05-15

    Zimmer Biomet Recalls T7 Driver Cannulated AO Due to Fracture Risk

    Zimmer Biomet is recalling 5,885 T7 Driver Cannulated AO units because they may fracture, bend, or shear during use.

    Product
    T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2875-2018·2018-08-29

    Zimmer Biomet Recalls Connecting Bolts Due to Material Error

    Zimmer Biomet is recalling 247 connecting bolts made from incorrect material, which may decrease fatigue strength and lead to fracture.

    Product
    Connecting Bolt, Model 14-442093
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-2594-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units Due to Fracture Risk

    Integra LifeSciences is recalling Mayfield Infinity XR2 Low Profile Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2593-2018·2018-08-08

    MAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk

    Integra LifeSciences is recalling 17 MAYFIELD Infinity XR2 Base Units because the knob assembly may fracture during use.

    Product
    MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2018·2018-08-08

    Integra LifeSciences Recalls Mayfield Spine Table Adaptors Due to Fracture Risk

    Integra LifeSciences is recalling 95 Mayfield Spine Table Adaptors because the knob assembly may fracture during use, posing a risk to patients.

    Product
    MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2018·2018-04-04

    Zimmer Biomet Recalls ACE Trochanteric Nail System Due to Performance Failure

    Zimmer Biomet is recalling the ACE Trochanteric Nail System after a device performance review failed to meet clinical survivorship criteria.

    Product
    ACE Trochanteric Nail System STER TROC NAIL 125 DEG X 9MM STER TROC NAIL 130 DEG X 9MM STER TROC NAIL 135 DEG X 9MM The Trochanteric Nail System is intended to treat stable and unstable proximal fractures of the femur including pertrochanteric fractures, intertrochanteric f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0596-2018·2018-02-21

    Zimmer Biomet Recalls Persona Partial Knee System Impactor Pads

    Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture during use.

    Product
    Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0603-2018·2018-02-21

    Exactech Orthopedic Surgical Tool Recalled for Fracture Risk

    Exactech is recalling 41 GPS Total Shoulder Application 3.2mm Vix Bits because they may fracture during use.

    Product
    Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-3100-2017·2017-09-06

    Smith & Nephew Recalls Polarstem Cardan Joints Due to Fracture Risk

    Smith & Nephew is recalling 402 Polarstem Cardan joints because the device may fracture or fail after multiple uses.

    Product
    smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·17142·2017-04-27

    Osprey Recalls Poco Child Backpack Carriers Due to Fall Hazard

    Osprey is recalling about 82,000 Poco child backpack carriers because children can slip through the leg openings, posing a fall hazard.

    Product
    Poco child carriers
    Category
    Consumer Product
    Distribution
    Distributed nationwide