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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