The Recall Desk

Manufacturer

Stryker Spine

29 recalls in our database name Stryker Spine as the manufacturing or recalling firm.

What the numbers show

Total
29
Critical
0
Severe
5
Most recent
2025-04-09

Of the 29 recalls from Stryker Spine we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (17%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 29

  • HighFDA (Devices)·Z-1488-2025·2025-04-09

    Stryker Monterey AL Implant Inserter Gold Button Detachment Risk

    Stryker Spine is recalling Monterey AL Implant Inserters due to a potential defect where the gold unlock button may separate from the device, compromising its function during spinal surgery.

    Product
    Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1489-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall

    Stryker Spine has recalled 56 units of the Monterey AL Implant Inserter due to potential separation of the gold unlock button. This could impair the device's function during surgical implant placement.

    Product
    Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1491-2025·2025-04-09

    Stryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation

    Stryker Spine is recalling the Monterey AL Implant Inserter (22mm, Catalog 48019140) due to potential separation of the gold unlock button from the device. The recall affects 41 units in the United States and 3 internationally.

    Product
    Monterey AL Implant Inserter; 22mm; Catalog 48019140.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-3210-2024·2024-10-02

    AVS Anchor-C Cervical Cage Instructions for Use Labeling Correction

    Stryker Spine recalled the electronic Instructions for Use revision 5 for the AVS Anchor-C Cervical Cage System because specific indications language for the US and Canada was inadvertently removed.

    Product
    AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2024·2023-12-27

    LITe Decompression Snake Arm cannot attach due to incorrect clamp component

    Stryker Spine is recalling 9 units of the LITe Decompression Snake Arm due to an incorrect clamp component that prevents proper attachment to the arm post shaft. Affected units were distributed in the US and internationally.

    Product
    LITe Decompression Snake Arm, REF 48080230
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2100-2021·2021-07-28

    Cortoss Bone Augmentation Material Recalled Due to Storage Temperature Excursion

    Stryker Spine is recalling 559 units of Cortoss Bone Augmentation Material 5cc Cartridges due to a 12-hour temperature excursion at the distribution center. The affected lot may not meet required storage conditions.

    Product
    Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2101-2021·2021-07-28

    Stryker Cortoss Bone Augmentation Material Recalled for Temperature Storage Violation

    Stryker Spine recalled Cortoss Bone Augmentation Material due to a 12-hour temperature excursion at the distribution center that could have compromised product sterility and efficacy.

    Product
    Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2021·2021-04-28

    Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk

    Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.

    Product
    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0092-2019·2018-10-17

    Stryker Spine AVS Aria Cage Recalled for Incorrect Marker Placement

    Stryker Spine is recalling five AVS Aria Cage units because the anterior and posterior markers were placed on the incorrect sides of the device.

    Product
    AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2016·2016-03-02

    Stryker Spine Recalls AccuLIF Tubing Sets Due to Interference

    Stryker Spine is recalling 413 AccuLIF PL and TL Tubing Sets because two potential interference conditions were identified with how the tubing attaches to the inserter.

    Product
    AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0828-2016·2016-03-02

    Stryker Aero-AL Impaction Handle Recalled for Jamming Defect

    Stryker Spine is recalling 31 Aero-AL Impaction Handles due to reported jamming when assembled to the Inserter guide.

    Product
    Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0270-2016·2015-11-18

    Stryker Spine Recalls Radius Rod to Rod Connectors for Missing Clearance

    Stryker Spine is recalling 42 units of Radius Rod to Rod Connectors because the device lacks the required FDA 510(k) clearance.

    Product
    Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to provide additional support during fusion using autograft or allograft in skeletally mature patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0222-2016·2015-11-11

    Stryker UniVise Spinous Process Fixation Plate System Inserter Recalled

    Stryker Spine is recalling 41 units of the UniVise Spinous Process Fixation Plate System Inserter because the inner shaft does not fit through the device.

    Product
    Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2015·2014-12-24

    Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture

    Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.

    Product
    Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
    Category
    Medical Device
    Distribution
    8 states
  • SevereFDA (Devices)·Z-2627-2014·2014-09-17

    Stryker Recalls Aria Inserter Devices Due to Product Fracturing

    Stryker Spine is recalling 57 units of Aria Standard and Specialty Implant Inserters because of complaints that the instruments fractured.

    Product
    Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in
    Category
    Medical Device
    Distribution
    24 states
  • SevereFDA (Devices)·Z-2626-2014·2014-09-17

    Stryker Recalls Aria Implant Inserters Due to Product Fracturing Complaints

    Stryker Spine is recalling 64 units of Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. The devices are used for spinal fusion procedures.

    Product
    Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal f
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1086-2014·2014-03-05

    Stryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints

    Stryker Spine is recalling 21 units of Specialty Straight Static Inserter Assemblies because customers reported fractures along the weld binding the handle to the shaft.

    Product
    Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implant insertion in to the disc space. The AVS navigator Peek Spacer System offers implants that are interbody fusion devices intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2014·2013-11-27

    Stryker Spine Recalls XIA Torque Wrenches Due to Fracturing Hex Tips

    Stryker Spine is recalling XIA and Mantis Redux torque wrenches because the hex tips may fracture during final tightening.

    Product
    Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court Allendale
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1976-2013·2013-08-28

    Stryker Oasys Midline Occiput Plate Recalled for Post-Operative Pin Fracture

    Stryker Spine is recalling Oasys Midline Occiput Plates because customer reports indicate post-operative fracture of the pin connecting the tulip head to the plate body.

    Product
    Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0893-2013·2013-03-06

    Stryker XIA 3 Iliac Screwdriver Recalled Due to Unthreading Risk

    Stryker Spine is recalling 46 units of the XIA 3 Iliac Screwdriver because the outer shafts may unthread during surgical use.

    Product
    Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is used to drive XIA 3 closed head Monoaxial and closed head Polyaxial screws into the Ilium. Orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0382-2013·2012-11-28

    Stryker Spine Recalls Specialty Audible Torque Wrenches Due to Fracturing Tips

    Stryker Spine is recalling 28 units of Specialty Audible Torque Wrenches because the hex tips have fractured during use.

    Product
    SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty Audible Torque Wrenches are used to final tighten the blocker of the Xia 3/ Mantis Redux Polyaxial Screws, Hooks, Monoaxial Scr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0381-2013·2012-11-28

    Stryker Mantis Torque Wrench Recalled for Hex Tip Fracture

    Stryker Spine is recalling 19 Mantis Torque Wrenches because the hex tip may fracture during use. The recall covers units distributed in the US and internationally.

    Product
    Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0380-2013·2012-11-28

    Stryker XIA 3 Torque Wrench Recalled Due to Hex Tip Fracture

    Stryker Spine is recalling 54 XIA 3 Torque Wrenches because the hex tip may fracture during use, posing a risk of injury to patients or providers.

    Product
    Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine SAS Z.I MARTICOT-33610-CESTAS-FRANCE +33 (0)5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine, 2 Pearl Ct. Allendale NJ 07401-1677 USA +1-201-780-8000 The Xia 3/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2013·2012-11-07

    Stryker Spine Recalls Aviator Drill Bits Due to Over-Drilling Risk

    Stryker Spine is recalling Aviator Drill Bits because they are 10 mm longer than Reflex Hybrid bits and not interchangeable, posing a risk of over-drilling.

    Product
    Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits
    Category
    Medical Device
    Distribution
    Distributed nationwide