The Recall Desk

Manufacturer

Genesys Orthopedic Systems, LLC

1 recall in our database name Genesys Orthopedic Systems, LLC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2013-03-20

Of the 1 recalls from Genesys Orthopedic Systems, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-0921-2013·2013-03-20

    Genesys Orthopedic Recalls 3.75mm Fixed Cervical Screws Due to Manufacturing Residue

    Genesys Orthopedic Systems is recalling 3.75mm x 12mm Fixed Cervical Screws because manufacturing residue may be present. The residue poses risks of infection, delayed fusion, or revision surgery.

    Product
    3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
Genesys Orthopedic Systems, LLC recalls · The Recall Desk