Howmedica Osteonics Corp. recalls MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Read the official notice →- Date
- 2024-10-16
- Country
- United States
- Brand
- Howmedica Osteonics
- Product
- MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia, Germany.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Howmedica Osteonics recalls
- 2026-03-25
USHowmedica Osteonics Corp. recalls MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and…
FDA · DeviceHowmedica Osteonics Corp.Domestic: Nationwide Distribution; International: Australia, Germany, Belgium,…Official notice →- 2025-12-31
- US
Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR)…
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice → - 2025-10-08
- US
Howmedica Osteonics Corp. recalls 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
FDA · DeviceHowmedica Osteonics Corp.International distribution in the country of United Kingdom.Official notice → - 2024-10-16
- US
Howmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and…
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.…Official notice → - 2024-09-04
- US
Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA · DeviceHowmedica Osteonics Corp.International distribution to the country of Australia.Official notice → - 2024-07-24
- US
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice →
Other drugs & medical recalls in the United States
- 2024-10-16
- US
AURIS HEALTH INC recalls Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure…
FDA · DeviceAURIS HEALTH INCWorldwide - US Nationwide distribution including in the states of MN, FL, NC,…Official notice → - US
Medtronic Navigation, Inc. recalls StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is…
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing…
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ,…Official notice → - US
Cook Incorporated recalls Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to…
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
FDA · DeviceCook IncorporatedInternational distribution to the country of Australia.Official notice → - US
Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that…
FDA · DeviceLuminex Molecular Diagnostics IncU Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO,…Official notice → - US
Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the countries of Belgium,…Official notice → - US
GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129;…
GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study…