The Recall Desk

Manufacturer

SeaSpine Inc

1 recall in our database name SeaSpine Inc as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2014-07-02

Of the 1 recalls from SeaSpine Inc 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-1841-2014·2014-07-02

    SeaSpine Recalls UCR 3mm Hex Large Axial Driver Due to Tip Deformation

    SeaSpine Inc is recalling seven units of the UCR 3mm Hex, Large Axial Driver because the tip may twist or become rounded during use.

    Product
    Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a surgical instrument used to implant and remove polyaxial screws of varying reduction heights provided with the Malibu", UCR, and NewPort" Systems. The Malibu", UCR, NewPort" Systems are intended to be used
    Category
    Medical Device
    Distribution
    5 states