Recall archive
9 recalls · page 1 of 1
Reported Nov 4, 2026
Precision Pointer Electromagnetic (8000-050-001)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand — Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the…
FDA (weekly enforcement report)
Reported May 29, 2024
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand · Product details — Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical…
FDA (openFDA device enforcement)
Reported May 15, 2024
Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand · Product · Product details — Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
FDA (openFDA device enforcement)
Reported Mar 15, 2023
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand — Device was shipped without having regulatory approval.
FDA (openFDA device enforcement)
Reported Mar 9, 2022
MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand — Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the…
FDA (openFDA device enforcement)
Reported Apr 28, 2021
DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand — Inability for the user to inject the paste from the syringe into the target location.
FDA (openFDA device enforcement)
Reported Sep 5, 2018
QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand · Product · Product details — After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
17 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 4, 2018
The Stryker Thoracic Pedicle Feeler 6002-350-000 is a smart instrument for remote control of the navigation software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Instruments Div.
Matched: Brand · Product · Product details · Reason for recall — Stryker Instruments and Stryker Leibinger GmbH & Co. KG are voluntarily recalling certain serial numbers Thoracic Pedicle Feelers that are used in…
13 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 15, 2017
QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Leibinger GmbH & Co. KG
Matched: Brand — An incorrect sterility status on the label, non-sterile products labeled as sterile
1 more product in this recall
FDA (openFDA device enforcement)
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