Stryker Spine

Complete recall history across all FDA and CPSC categories, 29 total recalls

Stryker Spine appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (29)

FDA medical device enforcement actions by Stryker Spine

Date Product Reason Class
Feb 28, 2025 Monterey AL Implant Inserter; 22mm; Catalog 48019140. Potential for the gold unlock button to separate from the inserter. Class II
Feb 28, 2025 Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Potential for the gold unlock button to separate from the inserter. Class II
Feb 28, 2025 Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Potential for the gold unlock button to separate from the inserter. Class II
Feb 28, 2025 Monterey AL Implant Inserter; 14/16mm; Catalog 48019120. Potential for the gold unlock button to separate from the inserter. Class II
Aug 23, 2024 AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision ... Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, sp... Class II
Nov 1, 2023 LITe Decompression Snake Arm, REF 48080230 Product arm was manufactured with the incorrect clamp component. As a result,... Class II
May 18, 2021 Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, ... The products experienced a 12-hour excursion from the required refrigerated t... Class II
May 18, 2021 Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, G... The products experienced a 12-hour excursion from the required refrigerated t... Class II
Mar 11, 2021 Tritanium X TL Instruments - intervertebral fusion device with bone graft, lu... Stryker identified non-conforming instruments that are components of the Trit... Class II
Aug 13, 2018 AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine A... The anterior and posterior markers on the cage were on the incorrect/opposite... Class II
Dec 18, 2015 Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manu... Reported jamming of the impaction handle when assembled to the Inserter guide... Class II
Dec 16, 2015 AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody de... There were two potential interference conditions identified with the way the ... Class II
Sep 25, 2015 Stryker Radius 5.5 to 3.5 Rod to Red Connector, REF 48664530. Intended to p... Stryker Spine is recalling Radius Rod to Rod Connector 5.5 to 3.5 mm (Catalog... Class II
Sep 8, 2015 Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine... The Inserter Inner Shaft would not fit through the Inserter. The inner diamet... Class II
Oct 6, 2014 Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002X... Stryker has received a complaint from customers relating to a fracture during... Class II
Jul 7, 2014 Specialty Aria Inserter, REF IS3021ARI, Non-Sterile, This instrument is ... Stryker has initiated the recall of its Aria Standard and Specialty Implant I... Class II
Jul 7, 2014 Stryker Aria Implant Inserter, REF 48758500, This instrument is part of ... Stryker has initiated the recall of its Aria Standard and Specialty Implant I... Class II
Dec 18, 2013 Specialty Straight Static Inserter Assembly Product Usage: This instru... Stryker has received complaints from customers relating to fracture along the... Class II
Sep 24, 2013 Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short... Multiple complaints have reported that the hex tip of the torque wrench fract... Class II
May 30, 2013 Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long... Stryker has received reports from customers indicating post-operative fractu... Class I
Dec 27, 2012 Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is u... Surgeons have experienced unthreading of the screwdrivers outer shafts during... Class II
Aug 9, 2012 Stryker XIA 3 TORQUE WRENCH REF 48237028 Manufactured by: Stryker pine... Multiple complaints have reported the hex tip of the torque wrench fracturing... Class II
Aug 9, 2012 Stryker MANTIS TORQUE WRENCH REF 48287028 Manufactured by: Stryker pin... Multiple complaints have reported the hex tip of the torque wrench fracturing... Class II
Aug 9, 2012 SPECIALTY AUDIBLE TORQUE WRENCH, XIA IS2217XLP MFG BY: STRYKER SPINE ... Multiple complaints have reported the hex tip of the torque wrench fracturing... Class II
Jul 5, 2012 Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spi... Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are... Class II
Apr 25, 2012 The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDA... The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly... Class II
Apr 23, 2012 LUXOR RETRACTOR BASE; Catalog Number: 48250030; Manufactured by: STRYKER Spin... Stryker received three reports involving blades of the Luxor Retractor becomi... Class II
Jan 13, 2012 Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z... Beginning in February 2011, Stryker Spine began receiving reports related to ... Class II
Mar 21, 2011 Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blo... Stryker Spine has received six reports regarding the breakage of one or more ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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