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.

226–249 of 249

  • SevereFDA (Devices)·Z-0659-2013·2013-01-16

    Zimmer Ardis Interbody System Inserter Recalled for Release Knob Issues

    Zimmer, Inc. is recalling 170 Ardis Interbody System Inserters because the release knob may be difficult to turn, potentially leaving the implant engaged in the patient.

    Product
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0594-2013·2013-01-02

    Zimmer Spine Ardis Inserter Recalled for Potential Spacer Fragmentation

    Zimmer, Inc. is recalling the Spine Ardis Inserter because excessive force can break the PEEK spacer, causing sharp fragments that may damage adjacent structures.

    Product
    Zimmer Spine Ardis Inserter, Rx, non-sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0537-2013·2012-12-26

    Zimmer Recalls Coonrad/Morrey Total Elbow Replacement Sets Due to Pin Error

    Zimmer, Inc. is recalling specific lots of Coonrad/Morrey Total Elbow Replacement Sets because they may contain an incorrect small inner pin instead of the required regular pin.

    Product
    COONMAD/MORREY TOTAL ELBOW ELBOW COMPONENT REPLACEMENT SET BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW ELBOW COMP REPLACEMENT-REG SET STERILE PROD CLASS: 4100 OPERATION:9000 QTY/PKG:1 Product Usage: The ulnar and humeral components are connected by placing the hollow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0461-2013·2012-12-12

    Terumo Recalls Sarns Aortic Cannulas Due to Plastic Flash Defect

    Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.

    Product
    24 Fr 8mm Soft Flow Ang Wire W/L The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0344-2013·2012-11-28

    Extremity Medical Recalls IO Fix IntraOsseous Fixation System Due to Screw Failure

    Extremity Medical LLC is recalling 120 units of the IO Fix IntraOsseous Fixation System because product event reports indicate lag screws may pass through washers during surgery.

    Product
    IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical.com; Customer Service: 888.499.0079. The Extremity Medical Screw and Washer System is intended for reduction and internal fixation of arthrodeses, osteotomies, intra- and extrarticular fractures and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0389-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads and fit issues.

    Product
    Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral Head Provisional 22mm +3.5 00789502220 VerSys Femoral Head Provisional 22mm -2 00789502230 VerSys Femoral Head Provisional 22mm +3 12/14 Neck Taper The provisional heads replicate final
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0394-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads and fit issues.

    Product
    00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Femoral Head Provisional 40mm +0 00789504003 VerSys Femoral Head Provisional 40mm +3.5 00789504004 VerSys Femoral Head Provisional 40mm +7 00789504005 VerSys Femoral Head Provisional 40mm +10.5 The prov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0391-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    . 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral Head Provisional 28mm +0 00789502803 VerSys Femoral Head Provisional 28mm +3.5 00789502804 VerSys Femoral Head Provisional 28mm +7 00789502805 VerSys Femoral Head Provisional 28mm +10.5 12/14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0400-2013·2012-11-28

    Zimmer Recalls Slotted Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0393-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    . 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral Head Provisional 36mm +0 00789503603 VerSys Femoral Head Provisional 36mm +3.5 00789503604 VerSys Femoral Head Provisional 36mm +7 00789503605 VerSys Femoral Head Provisional 36mm +10.5 12/14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2013·2012-11-28

    Zimmer Recalls Provisional Femoral Heads for Enhanced Surgical Instructions

    Zimmer, Inc. is recalling MIS 12/14 Slotted Provisional Femoral Heads to update surgical instructions regarding the visual location of displaced heads.

    Product
    00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780303603 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780303604 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780303605 MIS 12/14 Slotte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2013·2012-11-28

    Zimmer Recalls VerSys Provisional Femoral Heads for Surgical Technique Updates

    Zimmer, Inc. is recalling VerSys Provisional Femoral Heads to update surgical instructions regarding locating displaced heads and reducing fit issues.

    Product
    00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Femoral Head Provisional 32mm +0 00789503203 VerSys Femoral Head Provisional 32mm +3.5 00789503204 VerSys Femoral Head Provisional 32mm +7 00789503205 VerSys Femoral Head Provisional 32mm +10.5 12/14 Ne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2013·2012-11-14

    Medacta Recalls Quadra S Offset Broach Handle Due to Rivet Failure Risk

    Medacta USA Inc is recalling 12 units of the Quadra S Offset Broach Handle because a rivet may become loose during surgery, preventing the locking mechanism from functioning.

    Product
    Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0057-2013·2012-10-24

    Ethicon Recalls Hemorrhoidal Circular Staplers Due to Firing Defect

    Ethicon Endo-Surgery is recalling specific lots of PROXIMATE PPH and Transtar circular staplers because a firing defect may cause incomplete staple formation.

    Product
    Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resectio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2013·2012-10-24

    ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the distal tip of the driver may separate from the shaft after the implant is inserted.

    Product
    NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0064-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0063-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2470-2012·2012-10-03

    Alcon 23G Ophthalmic Cannula Recall Due to Loose Fit

    Alcon is recalling 23G non-valved trocar and infusion cannulas due to a loose fit that could cause detachment during ophthalmic surgery.

    Product
    This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm), Const
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2012·2012-08-29

    Exactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility

    Exactech, Inc. is recalling 70 Optetrak Proximal Tibial Spacers because they are dimensionally incompatible with the Logic Tibial Tray.

    Product
    OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals underg
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2168-2012·2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 4,411 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with three #2 sutures (white, COBRAID- blue), sterile Part Number: 72202897 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2166-2012·2012-08-15

    Smith & Nephew TWINFIX Ultra Ti Anchor Recall for Breakage Risk

    Smith & Nephew is recalling 4,661 units of TWINFIX Ultra Ti Anchors because the distal part may break during insertion into bone.

    Product
    Smith & Nephew 5.5 mm TWINFIX Ultra Ti Anchor with two #2 sutures(white, COBRAID-blue), sterile Part Number: 72202895 Product Usage: intended for use for the reattachment of soft tissue to bone
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2012·2012-08-08

    Integra Advansys Medial Lisfranc Plate Recalled for Surgical Technique Risk

    Integra LifeSciences is recalling Advansys Medial Lisfranc Plates because an incorrect surgical technique may cause potential rupture of the tibialis anterior tendon.

    Product
    Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthr
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1951-2012·2012-07-18

    Encision Recalls AEM Disposable Electrodes Due to Unanticipated Alarms

    Encision, Inc. is recalling 48 boxes of AEM Disposable Electrodes after two complaints reported unanticipated alarms from the AEM monitor, which could cause delays or complications during surgery.

    Product
    AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical proce
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1933-2012·2012-07-11

    Zimmer Recalls PathFinder NXT Pivoting Percutaneous Rod Holder

    Zimmer, Inc. is recalling 77 units of the PathFinder NXT Pivoting Percutaneous Rod Holder because the set screw may break, preventing the surgeon from removing the rod during surgery.

    Product
    PathFinder NXT Pivoting Percutaneous Rod Holder This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facilitate rod insertion, positioning, and orientation through the extender sleeves,
    Category
    Medical Device
    Distribution
    Distributed nationwide