The Recall Desk

Manufacturer

Genesys Orthopedics Systems, LLC

2 recalls in our database name Genesys Orthopedics Systems, LLC as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2017-10-25

Of the 2 recalls from Genesys Orthopedics 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.

1–2 of 2

  • HighFDA (Devices)·Z-0040-2018·2017-10-25

    Genesys Binary Screwdriver Recalled Due to Threaded Shaft Breakage

    Genesys Orthopedics is recalling 120 Binary Screwdrivers because the threaded inner shaft tip can break off during cervical screw insertion.

    Product
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adj
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2677-2014·2014-10-01

    Genesys Spine Recalls Circular Lock Screws Due to Material Error

    Genesys Orthopedics Systems is recalling 642 Circular Lock Screws from the TiLock Pedicle Screw System because a portion of the lot was manufactured with stainless steel instead of the specified titanium alloy.

    Product
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to f
    Category
    Medical Device
    Distribution
    Distributed nationwide