The Recall Desk

Hazard

Implant Malfunction recalls

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

What the numbers show

Total
14
Critical
0
Severe
3
Most recent
2023-07-12

Of the 14 implant malfunction recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (21%) 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 implant malfunction 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.

1–14 of 14

  • HighFDA (Devices)·Z-2067-2023·2023-07-12

    LinkSymphoKnee Knee Augment Recalled for Incorrect Screw Orientation

    Waldemar Link GmbH & Co. KG recalled LinkSymphoKnee Distal Femoral Augments due to incorrect screw orientation during manufacturing. The fixation screw may be inserted through the wrong side of the augment, affecting 20 units distributed across seven US states.

    Product
    LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0025-2023·2022-11-09

    Ranibizumab eye implant recalled for non-functioning delivery system

    Genentech is recalling Susvimo ocular implants (452 units nationwide) due to manufacturing defects in the drug delivery system. A few patients have experienced non-functioning implants.

    Product
    SUSVIMO — SUSVIMO (RANIBIZUMAB)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0140-2023·2022-11-02

    Stryker INBONE Tibial Tray recalled for oversized lock detail defect

    Wright Medical Technology is recalling one Stryker INBONE Tibial Tray due to an oversized tibial tray lock detail that exceeds product specifications and could affect device functionality.

    Product
    Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1820-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Screw Mechanism Recall

    Alphatec Spine is recalling the Atec Insignia Anterior Cervical Plate System due to potential disassociation or postoperative unlock of the screw blocking mechanism during or after cervical spine surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0358 Insignia, ACP, 3-Level, 58 mm, Rx Only, Non-Sterile, UDI: (01)00190376268606
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2021·2021-06-16

    Cervical Plate System screw locking mechanism may fail during or after surgery

    Alphatec Insignia Anterior Cervical Plate System screw blocking mechanism may disassociate during surgery or unlock afterward. No injuries reported.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0474 Insignia, ACP, 4-Level, 74 mm, Rx Only, Non-Sterile, UDI: (01)00190376268699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2020·2020-01-15

    Medacta Shoulder Implant Recall Due to Screw Insertion Limitation

    Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.

    Product
    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2020·2019-12-18

    Conformis Recalls iTotal CR Knee Replacement System Due to Fit Issues

    Conformis, Inc. is recalling the iTotal CR Knee Replacement System because the polyethylene inserts did not securely fit into the cobalt chrome tray implant.

    Product
    iTotal CR Knee Replacement System Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2019·2019-09-18

    Zimmer Biomet Recalls XP-XP Tibial Tray Due to Locking Bar Issue

    Zimmer Biomet is recalling 384 units of the XP-XP Tibial Tray - Interlok 83 mm because the locking bar may not fully engage.

    Product
    XP-XP Tibial Tray - Interlok 83 mm Item # 195759
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1775-2019·2019-06-19

    Conformis iTotal Hip Replacement System Recalled for Dimensional Discrepancy

    Conformis, Inc. is recalling 128 iTotal Hip Replacement System stems due to a 3mm discrepancy between approved and manufactured neck/head lengths.

    Product
    Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3090-2018·2018-09-19

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Set Screw Defect

    Zimmer Biomet is recalling Affixus Hip Fracture Nails because the set screw cannot advance or reverse from its original position.

    Product
    Affixus¿ Hip Fracture Nail Left 125¿ 11 mm x 320 mm, Item Number: 814411320
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-2068-2017·2017-05-17

    Zimmer Biomet Recalls Regenerex Patella Implants Due to Peg Shearing

    Zimmer Biomet is recalling 8,154 Regenerex Series A Patella implants because the pegs may shear after surgery.

    Product
    Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM Product Usage: The Regenerex Series A Patella can be used for any non-cemented resurfaced 3-peg patella application within the Vanguard Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2016·2016-05-18

    Stryker Recalls CinchLock Knotless Anchors Due to Internal Wire Breakage

    Stryker is recalling CinchLock Knotless Anchors after 13 reports of internal wire breakage upon deployment.

    Product
    CinchLock Flex Knotless Anchor with Inserter; Model number CAT02643; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2014·2014-08-06

    Zimmer Recalls 28 Distal Radial Volar Plates Due to Screw Locking Failure

    Zimmer, Inc. is recalling 28 units of the Distal Radial Volar Plate Lateral Column because a defect prevented screws from locking, causing them to pull through the plate.

    Product
    Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
    Category
    Medical Device
    Distribution
    2 states