The Recall Desk

Manufacturer

SAFE ORTHOPAEDICS LLC

1 recall in our database name SAFE ORTHOPAEDICS LLC as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2022-08-31

Of the 1 recalls from SAFE ORTHOPAEDICS 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

  • ModerateFDA (Devices)·Z-1572-2022·2022-08-31

    SteriSpine PS surgical screws recalled for patient label mislabeling

    FDA recalls 8 SteriSpine PS multi-axial fenestrated screw kits distributed in Maryland due to incorrect labeling on patient documentation. The patient labels list the wrong screw type, though other labeling and the devices themselves are correct.

    Product
    SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.
    Category
    Medical Device
    Distribution
    1 state