Tornier S.A.S. recalls stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit,…
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its…
Read the official notice →- Date
- 2025-04-16
- Country
- United States
- Brand
- Tornier
- Product
- stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit,…
- Classification
- Class II
- Units
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Tornier recalls
- 2026-02-11
USTornier, Inc recalls TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected…
- 2025-05-14
- US
Tornier S.A.S. recalls Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
FDA · DeviceTornier S.A.S.Blueprint Version 4.2.1 is only currently available in the US. Domestic…Official notice → - 2025-04-30
- US
Tornier, Inc recalls stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side: RIGHT, REF 9030103; Prosthesis, Elbow, Semi-Constrained,…
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092,…
FDA · DeviceTornier, IncOUS (International) Distribution to countries: Sweden, Australia, United…Official notice → - 2025-01-22
- US
Tornier S.A.S. recalls Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging…
- 2024-10-09
- US
Tornier, Inc recalls Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
- 2024-09-25
- US
Tornier, Inc recalls stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
FDA · DeviceTornier, IncUS Nationwide distribution in the states of IL, WI, AZ, NV, SD.Official notice →
Other drugs & medical recalls in the United States
- 2025-04-16
- US
CareFusion 303, Inc. recalls BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets…
Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the…
FDA · DeviceCareFusion 303, Inc.US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL,…Official notice → - US
Agilent Technologies, Inc. recalls GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the…
DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot, affected by a mosaic aberration that may result in Chromosome 12 baseline…
FDA · DeviceAgilent Technologies, Inc.US distribution to the state of: MA and OUS (International) distribution to…Official notice → - US
Medtronic Neuromodulation recalls Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model…
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
FDA · DeviceMedtronic NeuromodulationWorldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice → - US
Omnicell, Inc. recalls IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box,…
IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items…
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT, Model Number: MJ18004V2; 2) MJ BANDAGE HYDROCOLLOID…
There is a potential for the sterility of the device to be compromised.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide Distribution: US (Nationwide) and OUS (Foreign) to countries of:…Official notice → - US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, catalog number C11137 in vitro diagnostic device used for the quantitative, semi-quantitative, or…
Ground screws on Dxl 9000 PCB boards may cause electric shorts, leading to smoke and potentially delaying patient results. Smoke also poses a hazard to equipment and users.
FDA · DeviceBeckman Coulter, Inc.OUS (Foreign) distribution to countries of: Australia, Croatia, Czechia,…Official notice →