The Recall Desk

Manufacturer

Amendia, Inc dba Spinal Elements

1 recall in our database name Amendia, Inc dba Spinal Elements as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2017-12-20

Of the 1 recalls from Amendia, Inc dba Spinal Elements 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-0239-2018·2017-12-20

    FDA Recalls Piranha Cervical Spine Screws Due to Incorrect Length Marking

    The FDA is recalling 82 Piranha screws used in cervical spine surgery because some units marked as 12 mm actually measure 14 mm.

    Product
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical P
    Category
    Medical Device
    Distribution
    9 states
Amendia, Inc dba Spinal Elements recalls · The Recall Desk