Drugs & medicalClass II

Orthofix U.S. LLC recalls Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW,…

Polyaxial screws do not meet performance standards.

Read the official notice →
Date
2025-11-19
Country
United States
Brand
Orthofix U.S
Product
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW,…
Classification
Class II
Units
US Nationwide distribution in the states of California, North Carolina, and…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Orthofix U.S recalls

  1. 2026-07-22
  2. US
    Drugs & medicalClass II

    Orthofix U.S. LLC recalls Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral orthopedic/trauma external fixation device

    Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111

    FDA · DeviceOrthofix U.S. LLCUS: AZ CA CO CT FL GA ID IL IN LA MD MI MO MS MT NC NY OH OR SC SD TX UT VA WA…Official notice →
  3. 2025-12-17
  4. US
    Drugs & medicalClass III

    Orthofix U.S. LLC recalls Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿,…

    Labeling contains claims that are not consistently present.

    FDA · DeviceOrthofix U.S. LLCWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice →
  5. 2025-09-17
  6. US
    Drugs & medicalClass II

    Orthofix U.S. LLC recalls PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

    A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the…

    FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of CO, CA.Official notice →
  7. 2025-04-02
  8. US
    Drugs & medicalClass II

    Orthofix U.S. LLC recalls Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP,…

    The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

    FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of California, Colorado, and Missouri.Official notice →
All 5 Orthofix U.S recalls →

Other drugs & medical recalls in the United States

  1. 2025-11-19
  2. US
    Drugs & medicalClass II

    Philips Respironics, Inc. recalls SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini:…

    Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose voltage output when in use in the device. If the fault occurs while…

    FDA · DevicePhilips Respironics, Inc.US Nationwide distribution in the states of GA, ID, KY, NJ, NY and the country…Official notice →
  3. US
    Drugs & medicalClass II

    NeuroLogica Corporation recalls GM85 Digital Mobile X-ray imaging System; Model Number: GM85;

    The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture due to metal fatigue.

    FDA · DeviceNeuroLogica CorporationDomestic: US Nationwide Distribution. International: Australia, Belgium,…Official notice →
  4. US
    Drugs & medicalClass II

    Miach Orthopaedics recalls BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

    The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

    FDA · DeviceMiach OrthopaedicsUS Nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Generator, 5 mm x 37 cm FT10 SW Version 4.0.1.15 or lower;…

    Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.

    FDA · DeviceMedline Industries, LPUS Nationwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Philips Medical Systems DMC GmbH recalls Radiography 7300 C; Model Number: 712037;

    Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual…

    FDA · DevicePhilips Medical Systems DMC GmbHWorldwide Distribution: US (Nationwide) Distribution and OUS (International)…Official notice →
  7. US
    Drugs & medicalClass II

    Sonesta Medical AB recalls Brand Name: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software Version: N/A Product Description: Sonesta 6210 -…

    Video fluoroscopy table may contain inadequate weld on backrest bracket resulting in backrest dropping.

    FDA · DeviceSonesta Medical ABUS Distribution to NH only.Official notice →
See all drugs & medical recalls →