FDAJuly 30, 2018device
Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not thre...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications
What to do
FDA enforcement status: Terminated
Brands named
zimmer biomet spinezimmerzimmer biomet
UPCs
00889024003187
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABrand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software Version: N/A Product Description: Mixing Bowl and Spatula Component: N/A2026-03-30
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