The Recall Desk

Manufacturer

EBI Patient Care, Inc.

2 recalls in our database name EBI Patient Care, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2017-05-31

Of the 2 recalls from EBI Patient Care, 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.

1–2 of 2

  • HighFDA (Devices)·Z-2118-2017·2017-05-31

    EBI Patient Care Recalls Spinal Fusion Stimulators Due to Cytotoxicity

    EBI Patient Care is recalling 33 SpF-XL IIB implantable stimulators because routine monitoring found higher than allowed cytotoxicity levels.

    Product
    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2119-2017·2017-05-31

    EBI Patient Care Recalls SpF-PLUS Implantable Stimulators Due to Cytotoxicity

    EBI Patient Care, Inc. is recalling 33 SpF-PLUS Implantable Stimulators due to higher than allowed cytotoxicity levels found during routine process monitoring.

    Product
    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
    Category
    Medical Device
    Distribution
    Distributed nationwide