The Recall Desk

Hazard

Implant Failure Risk recalls

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

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2025-01-01

Of the 13 implant failure risk recalls 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 hazard tag

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

1–13 of 13

  • HighFDA (Devices)·Z-0751-2025·2025-01-01

    Daytona Small Stature Locking Caps recalled for manufacturing defects

    SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.

    Product
    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1958-2024·2024-06-12

    Vascular graft slider component separation poses implant failure risk

    Atrium Medical is recalling ADVANTA VXT vascular grafts due to separation of the slider swivel rod from its core. This structural defect could lead to device failure. Over 53,000 units are affected worldwide.

    Product
    ADVANTA VXT, 5X70, 1GDS, NH, STR-SW. Single-Ended Slider. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2024·2024-06-12

    LOSPA Patella Knee Component Recalled for Unsupported Expiration Date

    CORENTEC's LOSPA Patella Component knee implants are recalled due to an unsupported 10-year expiration date. Thirty-five units were distributed nationwide.

    Product
    LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2024·2024-06-12

    FDA Recalls FLIXENE Vascular Graft Devices for Component Separation

    Atrium Medical Corporation recalls FLIXENE vascular graft devices due to reported separation of the Slider GDS Swivel Rod from its core, which could affect device function.

    Product
    FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0919-2024·2024-02-07

    Knee Replacement Implants Recalled for Potential Material Oxidation

    Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.

    Product
    DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2024·2024-02-07

    Knee Replacement Implant Components Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0901-2024·2024-02-07

    Knee replacement poly insert recalled due to material oxidation risk

    Howmedica Osteonics recalled TRIDENT knee replacement poly inserts (Part 620-00-28J, Lot 38059601) due to potential UHMWPE material oxidation in components over 5 years old. Oxidation may affect material properties.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2024·2024-02-07

    Knee replacement implants recalled for potential material degradation

    Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.

    Product
    DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0884-2024·2024-02-07

    Knee replacement bearing insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.

    Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2022·2022-03-02

    Biomet Shoulder Implant Stem Recalled for Inadequate Coating Adhesion

    Biomet is recalling a Comprehensive Shoulder System implant component due to a defect in the porous plasma coating. The coating may not have sufficient adhesion strength, compromising the implant's structural integrity.

    Product
    Comprehensive Shoulder System Primary Shoulder Stem, Micro Length, Porous Plasma, 14 MM, 55 MM Long Item Number: 113614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2022·2022-03-02

    Shoulder Implant Stem Recalled for Defective Coating Adhesion

    Biomet is recalling Comprehensive Shoulder System Mini Humeral Stems due to defective porous plasma coating adhesion. Internal testing indicated affected parts may lack sufficient coating strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 15 MM, 83 MM Long Item Number: 113635
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2022·2022-03-02

    Biomet Shoulder Implant Stem Recalled for Coating Adhesion Defect

    Biomet recalls 9 Comprehensive Shoulder System Mini Humeral Stems due to potential coating adhesion defects. An incorrect rework process may have compromised the porous plasma coating adhesion strength.

    Product
    Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1792-2021·2021-06-09

    Zimmer Natural Nail cephalomedullary device angle mismatch recall

    Zimmer GmbH is recalling its Cephalomedullary Short Nail due to potential mix-up between 125 and 130 degree CCD angle versions. Eight units with Lot 3020731 are affected and distributed to CA, GA, KY, MD, and internationally.

    Product
    Zimmer Natural Nail -ZNN Cephalomedullary Short Nail 11.5 mm X 21.5 cm 125 CCD Left Ti-6Al-4V Alloy- intended for temporary fracture fixation and stabilization of the bone Item Number: 47-2493-211-11
    Category
    Medical Device
    Distribution
    4 states