Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 48 recalls
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury.…
Instructions for use for a foot plating system is being updated to remove the second option of requirements for sterilization which was 3 minutes exposure time at 134-137-degrees C (273-279-degrees F) and 40mBar for 5-10…
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location.…
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.…
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Due to complaints, loupe nose pads containing nickel may cause an allergic reaction.
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.
Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.