FDASeptember 21, 2020device
STANDARD RING 22MM X 28MM (TI) Product Number: 495-406 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s indiv...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCRowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards2026-07-02
- CPSCYamazuki Recalls Youth All-Terrain Vehicles (ATVs) Due to Risk of Serious Injury or Death from Crash; Violate Mandatory Standard for ATVs2026-06-25
- FDAAl Yaman Halawa Extra Pistachio 907g (31.994 oz) plastic jars, UPC 5 287000 098083, 12 retail units per case2026-06-09
- CPSCResistance Bands Recalled Due to Serious Injury from Impact Hazard; Imported by HomeProGym2026-05-21
- FDAFarm Rich Pizza Cheese Crunchers2026-05-19
- FDADairy House Ingredient Systems Vanilla Dairy Powder, 50 lb box2026-05-18
- FDALegacy Tex Dressing Stabilizer Blend #7604-50, 50lb bags2026-05-18
- FDADairy House Ingredient Systems Strawberry Dairy Powder 05#5072-50, 50 lb bags2026-05-18
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