Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 87 recalls
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.
Knee implants contain incorrect labeling (size and/or side incorrect)
Knee implants contain incorrect labeling (size and/or side incorrect)
Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
The remote interlock connector, which is required by 21 CFR 1040.10(f)(3), in the remote stop box was not installed the connector or was mechanically installed but not wired.…