Stryker Spine recalls
Stryker Spine appears in 29 official U.S. recall notices indexed by RecallRadar, most recently on 2025-04-09.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 29 |
|---|---|
| Published | 2012-07-25 to 2025-04-09 |
| By agency | FDA Device (29) |
| By classification | Class II (28), Class I (1) |
| By status | terminated (23), ongoing (6) |
| Distribution named in notices | AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, US, UT, VA, WI |
Recalls
- Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine
Reason: Potential for the gold unlock button to separate from the inserter. - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine
Reason: Potential for the gold unlock button to separate from the inserter. - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine
Reason: Potential for the gold unlock button to separate from the inserter. - Monterey AL Implant Inserter
FDA Device · Class II · 2025-04-09 · Stryker Spine
Reason: Potential for the gold unlock button to separate from the inserter. - AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures…
FDA Device · Class II · 2024-10-02 · Stryker Spine
Reason: Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed. - LITe Decompression Snake Arm, REF 48080230
FDA Device · Class II · 2023-12-27 · Stryker Spine
Reason: Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft. - Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
FDA Device · Class II · 2021-07-28 · Stryker Spine
Reason: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. - Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
FDA Device · Class II · 2021-07-28 · Stryker Spine
Reason: The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. - Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar
FDA Device · Class II · 2021-04-28 · Stryker Spine
Reason: Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger tha… - AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices in…
FDA Device · Class II · 2018-10-17 · Stryker Spine
Reason: The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage. - Stryker Aero-AL Impaction handle Catalog Number 48921007
FDA Device · Class II · 2016-03-02 · Stryker Spine
Reason: Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. - AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in…
FDA Device · Class II · 2016-03-02 · Stryker Spine
Reason: There were two potential interference conditions identified with the way the tubing set attaches to the inserter. - Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530
FDA Device · Class II · 2015-11-18 · Stryker Spine
Reason: Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog #486614530) because it does not have an associated 510(k) submisstion and subsequent clearance, which is required as this is a class 2 device. - Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile
FDA Device · Class II · 2015-11-11 · Stryker Spine
Reason: The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized. - Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile
FDA Device · Class II · 2014-12-24 · Stryker Spine
Reason: Stryker has received a complaint from customers relating to a fracture during the use of the Specialty Audible Torque Wrench in surgery. - Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is part of the Aria product brand
FDA Device · Class II · 2014-09-17 · Stryker Spine
Reason: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. - Stryker Aria Implant Inserter, REF 48758500, This instrument is part of the Aria product brand
FDA Device · Class II · 2014-09-17 · Stryker Spine
Reason: Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing. - Specialty Straight Static Inserter Assembly Product Usage: This instrument is a part of the Navigator product brand . It is used for implan…
FDA Device · Class II · 2014-03-05 · Stryker Spine
Reason: Stryker has received complaints from customers relating to fracture along the weld that binds the handle to the shaft of the static inserter. - Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -3…
FDA Device · Class II · 2013-11-27 · Stryker Spine
Reason: Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening. - Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini
FDA Device · Class I · 2013-08-28 · Stryker Spine
Reason: Stryker has received reports from customers indicating post-operative fracture of the pin that connects the tulip head to the plate body. - 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…
FDA Device · Class II · 2013-03-06 · Stryker Spine
Reason: Surgeons have experienced unthreading of the screwdrivers outer shafts during use. - 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…
FDA Device · Class II · 2012-11-28 · Stryker Spine
Reason: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. - 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://ww…
FDA Device · Class II · 2012-11-28 · Stryker Spine
Reason: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. - SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE 2 PEARL COURT ALLENDALE NJ 07401-1677 The Xia 3/Mantis Redux/Specialty…
FDA Device · Class II · 2012-11-28 · Stryker Spine
Reason: Multiple complaints have reported the hex tip of the torque wrench fracturing during final tightening. - 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…
FDA Device · Class II · 2012-11-07 · Stryker Spine
Reason: Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm. - The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Str…
FDA Device · Class II · 2012-08-29 · Stryker Spine
Reason: The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require steril… - Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blocker is a reusable instrument, sterilized prior to use
FDA Device · Class II · 2012-08-15 · Stryker Spine
Reason: Stryker Spine has received six reports regarding the breakage of one or more prongs at the extremity of the instrument. - LUXOR RETRACTOR BASE
FDA Device · Class II · 2012-08-15 · Stryker Spine
Reason: Stryker received three reports involving blades of the Luxor Retractor becoming disassembled from the base causing the retractor to collapse insitu. - Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www…
FDA Device · Class II · 2012-07-25 · Stryker Spine
Reason: Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.