Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 85–96 of 105 recalls
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging.
Due to a potential open seal in the sterile barrier packaging .
Due to a potential open seal in the sterile barrier packaging .
Due to a potential open seal in the sterile barrier packaging .
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.
Customer-designed sterile surgical procedure packs contain latex components as specified; but, the content label sealed within the transparent sterile pouch contains the symbol for a latex-free product.…