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.
Read the official notice →- Date
- 2025-12-17
- Country
- United States
- Brand
- Orthofix U.S
- Product
- Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿,…
- Classification
- Class III
- Units
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Orthofix U.S recalls
- 2026-07-22
US
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 →- 2025-11-19
US
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.
FDA · DeviceOrthofix U.S. LLCUS Nationwide distribution in the states of California, North Carolina, and…Official notice →- 2025-09-17
US
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…
- 2025-04-02
US
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 →
Other drugs & medical recalls in the United States
- 2025-12-17
US
C.R. Bard Inc recalls BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
Labeling discrepancy; Ureteral stent actual size may not match the actual product label.
FDA · DeviceC.R. Bard IncWorldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA,…Official notice →US
Medline Industries, LP recalls Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
US
Cardinal Health 200, LLC recalls ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T…
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
FDA · DeviceCardinal Health 200, LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice →US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee…
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US distribution to states of: AL, GA, and TX.Official notice →US
Beckman Coulter, Inc. recalls Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the…
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could…
US
Bard Peripheral Vascular Inc recalls Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt…
FDA · DeviceBard Peripheral Vascular IncUS Nationwide distribution in the states of CA, MN, IN, MI, LA.Official notice →