The Recall Desk

Hazard

Assembly Failure recalls

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

What the numbers show

Total
32
Critical
0
Severe
0
Most recent
2026-08-12

Of the 32 assembly 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 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 assembly 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.

1–25 of 32

  • HighFDA (Devices)·Z-2885-2026·2026-08-12

    U2 Total Knee System Femoral Valgus Adaptor Recall

    United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1403-2025·2025-03-26

    Shoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly

    Zimmer Orthopedics recalls shoulder prosthesis models due to excess material in the taper that prevents proper surgical assembly. Five complaints reported.

    Product
    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2025·2025-01-22

    Stryker Blueprint Glenoid Pin Guide May Disassemble During Shoulder Surgery

    The metal tube of the Stryker Blueprint Glenoid Pin Guide may disassemble from the plastic handle. This can prevent the guidance system from detecting the device, potentially prolonging surgery or requiring a switch to conventional surgical methods.

    Product
    Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0377-2024·2023-11-29

    Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly

    Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.

    Product
    Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2105-2023·2023-07-12

    Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect

    Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.

    Product
    Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0548-2022·2022-02-09

    INTEGRA SURFIX ALPHA Torx 10 Screwdriver Out of Specification Recalled

    Smith & Nephew recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10 units because they are out of specification and may not mate properly with the Surfix Alpha Lock screw.

    Product
    INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2947-2018·2018-09-05

    Civco Needle Guide Recall Due to Missing or Inadequate Adhesive

    Civco Medical Instruments is recalling 3 units of CIVCO Needle Guides because missing or inadequate adhesive may fail to hold the cannula in place.

    Product
    CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1173-2018·2018-04-04

    Biomet Recalls Orthopedic Implants Due to Screw Hole Mismatch

    Biomet is recalling 634 Zimmer Biomet Comprehensive Segmental Revision System implants because a screw hole mismatch may prevent proper assembly during surgery.

    Product
    Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0834-2018·2018-03-07

    DePuy Orthopaedics Recalls DELTA XTEND Reverse Shoulder System Implants

    DePuy Orthopaedics is recalling DELTA XTEND Reverse Shoulder System implants because the epiphysis may not assemble to the stem, potentially causing surgical delays.

    Product
    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0452-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0423-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0428-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because set screws and sleeves were found out of place during rework, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a set screw and sleeve assembly may have shifted during rework, potentially preventing proper product assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0447-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0481-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0475-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework process may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0450-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing rework error may have displaced internal components, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0457-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect

    Zimmer Biomet is recalling 638 Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0471-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of the Affixus Hip Fracture Nail because a manufacturing rework process caused set screws and sleeves to shift, potentially preventing proper assembly.

    Product
    Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0444-2018·2018-02-07

    Zimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect

    Zimmer Biomet is recalling 638 units of Affixus Hip Fracture Nails because a manufacturing defect may prevent proper assembly of the device.

    Product
    Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
    Category
    Medical Device
    Distribution
    Distributed nationwide