The Recall Desk

Hazard

Surgical Complication recalls

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

What the numbers show

Total
249
Critical
3
Severe
37
Most recent
2026-07-01

Of the 249 surgical complication recalls we have scored against our rubric, 3 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 37 (15%) 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 surgical complication 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.

176–200 of 249

  • HighFDA (Devices)·Z-1383-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 212 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1387-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 317 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risk

    Synthes (USA) Products LLC is recalling 289 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if a surgeon attempts to remove it.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1386-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks During Removal

    Synthes (USA) Products LLC is recalling 378 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures if a surgeon attempts to remove it.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1384-2016·2016-04-20

    Synthes Recalls SYNTHECEL Dura Repair Due to Adhesion Risks

    Synthes (USA) Products LLC is recalling 200 units of SYNTHECEL Dura Repair because the device may adhere to anatomical structures, posing risks if removal is attempted.

    Product
    SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0787-2016·2016-02-17

    DePuy SIGMA HP MBT Non-Keel Punch Knee Instrument Recalled

    DePuy Orthopaedics is recalling 351 SIGMA HP MBT Non-Keel Punch Knee Instruments due to a design defect that may cause surgical complications.

    Product
    SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0700-2016·2016-02-10

    Smith & Nephew Recalls Oversized Biosure Ratchet Driver for Orthopedic Screws

    Smith & Nephew is recalling nine Biosure Ratchet Drivers because they are oversized and may not fit screws properly or may cause screws to stick.

    Product
    Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0625-2016·2016-01-20

    Zimmer Biomet Recalls Virage OCT Spinal Fixation System Due to Set Screw Defect

    Zimmer Biomet is recalling the Virage OCT Spinal Fixation System because set screw staking is out of specification, which can interfere with rod insertion.

    Product
    Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
    Category
    Medical Device
    Distribution
    20 states
  • HighFDA (Devices)·Z-0573-2016·2016-01-13

    Smith & Nephew Recalls Mislabelled 35mm Patellar Knee Implant Components

    Smith & Nephew is recalling 20 units of 35mm patellar knee implants incorrectly labeled as 32mm. The size mismatch prevents proper alignment of pegs during surgery.

    Product
    Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0482-2016·2015-12-30

    Cardica Recalls MicroCutter Xchange 30 Blue Cartridges Due to Firing Defect

    Cardica, Inc. is recalling MicroCutter Xchange 30 Blue Cartridges because they may fail to fire staples completely, potentially causing incomplete tissue transection or anastomosis during surgery.

    Product
    MicroCutter Xchange 30 Blue Cartridge, FG-025320; The MicroCutter XCHANGE 30 Blue Cartridge and MicroCutter XCHANGE 30 Blue Curved Tip Cartridge contain 316L stainless steel staples. The cartridges are used with the MicroCutter XCHANGE 30 Stapler, which is a single patient devic
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0224-2016·2015-11-11

    Mako RIO Robotic System Components Recalled for Damaged Locking Pins

    Mako Surgical Corporation is recalling RIO system locking pins and connectors because the pins are damaged during assembly.

    Product
    Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0026-2016·2015-10-14

    Ortho Solutions Recalls UltOS 3.5mm Locking Screws Due to Manufacturing Defect

    Ortho Solutions Inc is recalling 875 units of UltOS 3.5mm locking screws because the locking thread feature was not manufactured to specification, creating a risk that the screw may not lock onto the plate.

    Product
    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2794-2015·2015-09-30

    Synthes Dynamic Locking Screw System Recalled for Pin Breakage

    Synthes (USA) Products LLC is recalling Dynamic Locking Screw Systems due to pin breakage during implant removal. This notice extends to additional consignees identified after a previous recall.

    Product
    Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2738-2015·2015-09-16

    Trilliant Gridlock Screw Driver Bits Recalled for Out-of-Specification Dimensions

    Trilliant Surgical Ltd. is recalling 108 units of Gridlock Screw Driver Bits because they are out of specification, which may cause screw heads to strip during surgery.

    Product
    2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-2490-2015·2015-09-09

    Trilliant Surgical Recalls Out-of-Specification Fibula Plates

    Trilliant Surgical Ltd. is recalling 28 units of VL Gridlock Fibula Plates because insufficient thread depth may limit locking screw functionality.

    Product
    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive pr
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2315-2015·2015-08-05

    Tornier Aequalis Humeral Nail Targeting Jig Recalled for Mast Separation

    Tornier, Inc. is recalling 99 Aequalis Humeral Nail Targeting Jigs because the mast can separate from the boom, potentially affecting surgical alignment and screw fixation.

    Product
    Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2072-2015·2015-07-22

    Biomet Recalls A.L.P.S. Medium Bone Plate Forceps Due to Assembly Error

    Biomet is recalling 223 units of A.L.P.S. Medium Bone Plate Forceps because they were assembled with incorrect grip arm tips, potentially preventing surgeons from clamping plates to bone.

    Product
    A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1989-2015·2015-07-15

    Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides

    Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.

    Product
    Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1694-2015·2015-06-10

    Zimmer Recalls 4.5mm Cortical Screws for M/DN Intramedullary Nail System

    Zimmer, Inc. is recalling 4.5mm Cortical Screws for the M/DN system because they are not compatible with the device, potentially causing surgical complications.

    Product
    Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1641-2015·2015-05-27

    Ethicon Endo-Surgery Recalls Echelon Vascular White Reloads Due to Staple Line Defect

    Ethicon Endo-Surgery is recalling 6,744 Echelon Vascular White Reloads because an internal inspection found a production issue that may cause the cartridge to deploy an incomplete staple line.

    Product
    ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Product Usage: The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1492-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Spec Deviations

    Wright Medical Technology is recalling 270 units of the Crosscheck Plating System because specific dimensions are out of specification, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 308 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1489-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 242 units of the Crosscheck Plating System because dimensional specifications are out of range, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1486-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Dimensional Defects

    Wright Medical Technology is recalling 102 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1496-2015·2015-04-29

    Wright Medical Recalls Crosscheck Plating System Due to Specification Defects

    Wright Medical Technology is recalling 372 units of the Crosscheck Plating System because dimensional specifications are out of tolerance, posing a risk of intraoperative malfunction.

    Product
    CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide