The Recall Desk

Manufacturer

Stelkast Co

3 recalls in our database name Stelkast Co as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2015-01-21

Of the 3 recalls from Stelkast Co we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) 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.

1–3 of 3

  • ModerateFDA (Devices)·Z-0970-2015·2015-01-21

    Stelkast Recalls EXp Tibial Inserts Due to Manufacturing Defect

    Stelkast Co is recalling 553 EXp Tibial Inserts because a missing lead-in radius may make it difficult to lock the inserts into tibial trays.

    Product
    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstruct
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2136-2013·2013-09-11

    Stelkast Recalls Distal Femoral Augments Due to Sterility Breach

    Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.

    Product
    SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1066-2013·2013-04-17

    Stelkast Cross-over Acetabular Shell and Liner Hip System Recalled

    Stelkast Co is recalling 254 units of the Cross-over Acetabular Shell and Liner Hip System due to difficulty engaging and securing the liner.

    Product
    Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474-52, SC3459-52, and SC3460-52. Intended for use in reconstruction of the articulating surface of the acetabular portion of the hip.
    Category
    Medical Device
    Distribution
    Distributed nationwide