The Recall Desk

Hazard

Implant Failure recalls

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

What the numbers show

Total
89
Critical
0
Severe
9
Most recent
2026-08-05

Of the 89 implant failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (10%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all implant failure 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 89

  • HighFDA (Devices)·Z-0471-2023·2022-12-21

    Knee implant tibial component recalled for higher revision rates

    Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.

    Product
    NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0468-2023·2022-12-21

    Zimmer Recalls NexGen Stemmed Tibial Components Due to Higher Revision Rates

    Zimmer Inc. is recalling NexGen Option Stemmed Tibial Components due to clinically and statistically significant higher revision rates when used with specific femoral components. The components are being removed from inventory.

    Product
    NexGen Option Stemmed Tibial Component Size 5, Item Number 00-5986-047-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0420-2023·2022-12-14

    Spinal implant screws recalled for potential weld separation

    Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1732-2022·2022-09-21

    Exactech GXL Acetabular Hip Implant Liners Recalled for Accelerated Wear

    Exactech GXL acetabular hip implant liners may have been packaged in non-conforming bags, which could contribute to accelerated device wear. Approximately 17,929 units were distributed worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS, REF 130-32-51 b. NOVATION GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS, REF 130-36-52 c. NOVATION GXL LINER NEUTRAL, 40MM ID, GROUP 3 CUPS, REF 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2022·2022-06-08

    Hip Stem Prosthetic Missing Plasma Coating in Manufacturing Lot

    MicroPort Orthopedics is recalling one manufacturing lot of PROFEMUR PLASMA Z CLASSIC hip stem prosthetics due to missing plasma-spray coating in the proximal region of the implant stem.

    Product
    PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2022·2022-03-02

    Hip implant revision system recalled due to inadequate coating adhesion

    Biomet is recalling 19 units of the Arcos Modular Revision Hip System because an incorrect rework process may have weakened the coating's adhesion strength, posing a potential implant failure risk.

    Product
    Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0674-2022·2022-03-02

    Comprehensive Shoulder System Mini Humeral Stem Recalled for Coating Adhesion Defect

    Biomet recalls 11 units of its Comprehensive Shoulder System Mini Humeral Stem due to potential coating adhesion defects. An unvalidated rework process was applied to vendor-coated parts, risking implant failure.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 11 MM, 83 MM Long Item Number: 113631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2022·2022-01-19

    Orthopaedic Implant Stems Recalled for Undersized Spigot Bore Defect

    DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0237-2022·2021-11-24

    Hip implant stem missing surface treatment affecting seven units

    OmniLife Science is recalling 7 units of the OMNI K2 Hip Stem due to missing grit blasting on the proximal surface, a defect that could lead to implant loosening and revision surgery. The recall affects units distributed to Colorado and Virginia.

    Product
    OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0160-2022·2021-10-27

    Bone Screw Labeling Error: Actual Length May Not Match Package Label

    Limacorporate is recalling bone screws (REF 8420.15.010) because the actual length of the screws may not correspond to the length stated on the package label, potentially affecting proper surgical placement and implant stability.

    Product
    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2329-2021·2021-08-25

    Triathlon orthopaedic implant baseplate recalled for assembly defect

    Howmedica Osteonics is recalling the Triathlon Prim CEM baseplate (Lot JHS2H) due to a manufacturing defect that may prevent the insert from locking properly on the implant.

    Product
    Triathlon Prim CEM FXD BPLT 7, Catalog No. 5520B700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2021·2021-08-18

    Biomet Hip Implant Cone Bodies Recalled Due to Fretting Corrosion Risk

    Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2021·2021-08-18

    Arcos Hip Implant Component Recalled for Potential Device Failure

    Biomet recalled 10 units of Arcos hip implant components (lot 934870) nationwide due to potential inner taper corrosion and device failure that may require surgical intervention.

    Product
    Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Risk Premature Wear

    Exactech hip implant liners may experience premature wear and edge-loading in certain patient configurations, according to this Class II recall of 89,050 units distributed nationwide.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2127-2021·2021-07-28

    Exactech Connexion GXL Hip Implant Liners Recall Risk of Premature Wear

    Exactech is recalling 89,050 Connexion GXL acetabular hip implant liners due to risk of edge-loading and premature wear in certain patient configurations and surgical placements.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized, 32mm. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2115-2021·2021-07-28

    Exactech Hip Implant Liners Recalled Due to Premature Wear Risk

    Exactech is recalling 89,050 Connexion GXL acetabular polyethylene hip implant liners due to risk of premature prosthesis wear in certain patient configurations and surgical positioning scenarios.

    Product
    Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm ID. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1794-2021·2021-06-16

    WishBone Medical Plate and Screw System Engineering Specification Nonconformity Recall

    Wishbone Medical is recalling WishBone Medical Plate and Screw System implants due to nonconformities in engineering specifications. The recall affects 60 units distributed in Virginia, Pennsylvania, and Indiana.

    Product
    WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1815-2021·2021-06-16

    Anterior Cervical Plate System Recalled for Potential Screw Mechanism Failure

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0250 Insignia, ACP, 2-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268538
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1821-2021·2021-06-16

    Anterior Cervical Plate System Screw Blocking Mechanism May Disassociate

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism. The screws may disassociate or unlock during or after surgery, risking implant failure.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0360 Insignia, ACP, 3-Level, 60 mm, Rx Only, Non-Sterile, UDI: (01)00190376268613
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1816-2021·2021-06-16

    Alphatec Insignia Cervical Plate System Screw Locking Mechanism May Disassociate or Unlock

    Alphatec Spine is recalling the Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism that could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0350 Insignia, ACP, 3-Level, 50 mm, Rx Only, Non-Sterile, UDI: (01)00190376268569
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2021·2021-06-16

    Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine recalls Atec Insignia Anterior Cervical Plate Systems because the screw blocking mechanism may fail during or after surgery. The mechanism may disassociate or unlock, potentially compromising implant stability.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0362 Insignia, ACP, 3-Level, 62 mm, Rx Only, Non-Sterile, UDI: (01)00190376268620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2021·2021-06-16

    Anterior cervical plate system screw blocking mechanism may disassociate

    Alphatec Spine Inc. is recalling the Atec Insignia anterior cervical plate system because the screw blocking mechanism may disassociate intraoperatively or unlock postoperatively. No injuries reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0236 Insignia, ACP, 2-Level, 36 mm, Rx Only, Non-Sterile, UDI: (01)00190376268385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1803-2021·2021-06-16

    Cervical Spine Plate System Screw Mechanism May Disassociate or Unlock

    Alphatec Spine recalls its Atec Insignia Anterior Cervical Plate System due to a potential defect in the screw blocking mechanism, which may disassociate or unlock during or after spinal surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0120, Insignia, ACP, 1-Level, 20 mm, Rx Only, Non-Sterile, UDI: (01)00190376268460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2021·2021-06-16

    Anterior cervical plate system screw mechanism may disassociate during or after surgery

    Alphatec Spine's Atec Insignia Anterior Cervical Plate System has a potential defect where the screw blocking mechanism may disassociate during or after surgery, which could compromise spinal stabilization.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0118, Insignia, ACP, 1-Level, 18 mm, Rx Only, Non-Sterile, UDI: (01)00190376268446
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2021·2021-06-16

    Alphatec Insignia Cervical Plate System: Screw Mechanism Disassociation Risk

    Alphatec recalls the Insignia Anterior Cervical Plate System due to risk that the screw blocking mechanism may disassociate during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0468 Insignia, ACP, 4-Level, 68 mm, Rx Only, Non-Sterile, UDI: (01)00190376268675
    Category
    Medical Device
    Distribution
    Distributed nationwide