Freiburg Im Breisgau, N/A, Germany
Stryker Leibinger GmbH & Co. KG recalls
6 recalls recorded since 2018, most recently on 4 April 2024. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)3
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 April 2024
- Reason
- 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 reference point of the pointer or suction.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1885-2024
- 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image g
Ongoing Class II Medical devices
- Recall started
- 29 March 2024
- Reason
- Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1785-2024
- Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614
Ongoing Class II Medical devices
- Recall started
- 6 December 2022
- Reason
- Device was shipped without having regulatory approval.
- Distribution
- Distribution of one unit only to a single customer in MA (USA)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1234-2023
- Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Terminated Class II Medical devices
- Recall started
- 29 December 2021
- Terminated
- 21 December 2023
- Reason
- Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side.
- Distribution
- Worldwide distribution - US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0715-2022
- MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032
Terminated Class II Medical devices
- Recall started
- 1 April 2021
- Terminated
- 19 December 2022
- Reason
- Inability for the user to inject the paste from the syringe into the target location.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Germany, Italy, France, Australia, Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1436-2021
- DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden
Terminated Class II Medical devices
- Recall started
- 22 June 2018
- Terminated
- 8 July 2019
- Reason
- After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.
- Distribution
- US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2910-2018, Z-2902-2018, Z-2901-2018, Z-2912-2018, Z-2899-2018, Z-2915-2018, Z-2900-2018, Z-2911-2018, Z-2913-2018, Z-2907-2018, Z-2903-2018, Z-2914-2018 and 6 more
- AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium
- QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium
- QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium
- AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium
- QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load
- AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium
- QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.
- AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium
- and 10 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.