Recall archive
19 recalls · page 1 of 1
Reported Aug 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand · Product · Product details — Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 23, 2025
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 3, 2024
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand · Product · Product details — The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
FDA (openFDA device enforcement)
Reported Mar 8, 2023
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand · Product · Product details · Reason for recall — Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the…
FDA (openFDA device enforcement)
Reported May 4, 2022
Smart Toe II Intramedullary Arthrodesis Implant
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients…
FDA (openFDA device enforcement)
Reported Aug 11, 2021
Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The devices have a different inner diameter than the diameter specified on the outer box label.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 25, 2020
Osteosynthesis Compression Staple EasyClip
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when…
FDA (openFDA device enforcement)
Reported Jun 24, 2020
Stryker Locking Screw, Fully Threaded S2 05x35 mm Catalog Number: 17965035S - Product Usage: Stryker implants are…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand · Product · Product details — Seal integrity of the blister pack may be compromised and sterility cannot be assured
14 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2020
Stryker T2 Alpha Delta Strike Plate IMN Instruments - part of the IMN Instruments System and is used to support…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand · Product · Product details — Instrument can break at the level of the thread when being exposed to high forces during nail implantation or removal which can lead to complications…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 4, 2019
Endotrig ETF Hook Blade, Catalog Number 1052-1 The EPF system is designed for the treatment of plantar fasciosis. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The seal integrity of the sterile bag containing the kits may be compromised.
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 26, 2019
Endotrac ECTR Hook/Triangle Blade Kit, Catalogue Number 2056-1
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The seal integrity of the sterile bag containing the kits may be compromised.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2019
Instrument Tray, Basic T2 Femur Long Catalog #: 1806-9900 Product Usage: Knee Arthroplasty
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The faceplates may incorrectly identify the T2 Basic Long Instrument Set as T2 Basic Short Instrument Set.
FDA (openFDA device enforcement)
Reported Nov 7, 2018
Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or…
FDA (openFDA device enforcement)
Reported Aug 29, 2018
Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand · Product · Product details — Incomplete seal on the Tyvek lid may compromise the sterility of the device
FDA (openFDA device enforcement)
Reported Jul 18, 2018
Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 27, 2018
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm
FDA (openFDA device enforcement)
Reported May 2, 2018
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker GmbH
Matched: Brand — The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
FDA (openFDA device enforcement)
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