Stryker GmbH

Complete recall history across all FDA and CPSC categories — 68 total recalls

Stryker GmbH 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 (68)

FDA medical device enforcement actions by Stryker GmbH. Showing most recent 50.

Date Product Reason Class
May 28, 2025 Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catal... Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with... Class II
May 22, 2025 Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN)... Class II
May 22, 2025 Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN)... Class II
Mar 28, 2025 Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; The metal ring at the end of the Guide Wire with Ruler Tube may detach from t... Class II
Mar 28, 2025 Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; The metal ring at the end of the Guide Wire with Ruler Tube may detach from t... Class II
May 9, 2024 Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffman... The adjustment ring on the device may become loose resulting in the wire tens... Class II
Feb 7, 2023 stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic ex... Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone... Class II
Mar 28, 2022 Smart Toe II Intramedullary Arthrodesis Implant The nickel-sensitivity statement on the outer carton may be partially covered... Class II
May 27, 2021 Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-11 (SPI Elast. Sleeve 8-11), C... The devices have a different inner diameter than the diameter specified on th... Class II
May 27, 2021 Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), C... The devices have a different inner diameter than the diameter specified on th... Class II
Sep 25, 2020 Osteosynthesis Compression Staple EasyClip The device has the potential to release nickel above the acceptable margin of... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Pro... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S ... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x35 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x50 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker End Cap T2 Humerus ¿6mm, 15mm height Catalog Number: 18300015S - P... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker 1 End Cap T2 Humerus ¿6mm, 5mm height Catalog Number: 18300005S - ... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: ... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 1896... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker End Cap, Std, Ti Gamma3 Catalog Number: 30051100S - Product Usage: ... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker End Cap T2 Tibia +10 mm Catalog Number: 18220010S - Product Usage:... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Humerus ¿4x32 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
May 7, 2020 Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Pr... Seal integrity of the blister pack may be compromised and sterility cannot b... Class II
Dec 5, 2019 Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instrum... Instrument can break at the level of the thread when being exposed to high fo... Class II
Nov 21, 2019 Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - P... Pin To Rod Coupling could not clamp the pin and rod as intended Class II
Jul 25, 2019 Endotrac ECTR Triangle Blade, Angled, Catalog Number 2054A-1 The EPF syst... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac ECTR Hook Blade, Angled, Catalog Number 2055A-1 The EPF system i... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac EPF/EGR Triangle Blade, Angled, Catalog Number 3054A-1 The EPF s... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac ECTR Hook Blade, Catalog Number 2055-1 The EPF system is designe... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac ECTR Triangle Blade, Catalog Number 2054-1 The EPF system is des... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac ECTR Push Blade, Catalog Number 2053-1 The EPF system is designe... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endintrak¿ 2 Hook Blade, Angled, Catalog Number 4058A-1 The EPF system is... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac EPF/EGR Hook Blade, Angled, Catalog Number 3055A-1 The EPF syste... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac EPF/EGR Triangle Blade, Catalog Number 3054-1 The EPF system is ... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endintrak 2 Hook Blade, Catalog Number 4058-1 The EPF system is designed ... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac EPF/EGR Push Blade, Catalog Number 3053-1 The EPF system is desi... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrac EPF/EGR Hook Blade, Catalog Number 3055-1 The EPF system is desi... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jul 25, 2019 Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed ... The seal integrity of the sterile bag containing the kits may be compromised. Class II
Apr 30, 2019 Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1 The seal integrity of the sterile bag containing the kits may be compromised. Class II
Apr 30, 2019 Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1 The seal integrity of the sterile bag containing the kits may be compromised. Class II
Jan 21, 2019 Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage... The faceplates may incorrectly identify the T2 Basic Long Instrument Set as ... Class II
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. P... The press fit connection of the Angular Sleeve and pin of the U-Joint and Cli... Class II
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 131mm-191mm, Model Number 4935-0-030. ... The press fit connection of the Angular Sleeve and pin of the U-Joint and Cli... Class II
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. ... The press fit connection of the Angular Sleeve and pin of the U-Joint and Cli... Class II
Aug 28, 2018 Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. ... The press fit connection of the Angular Sleeve and pin of the U-Joint and Cli... Class II
Jul 26, 2018 Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: H... When creating a correction plan with the Correct Axial First button selecte... Class II
Jun 27, 2018 Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T... Incomplete seal on the Tyvek lid may compromise the sterility of the device Class II

View all 68 device recalls →

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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