The Recall Desk

Manufacturer

Small Bone Innovations, Inc.

2 recalls in our database name Small Bone Innovations, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2014-06-11

Of the 2 recalls from Small Bone Innovations, 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

  • ModerateFDA (Devices)·Z-1720-2014·2014-06-11

    Small Bone Innovations Recalls Non-Sterile RingFIX Olive Wires

    Small Bone Innovations is recalling non-sterile RingFIX Olive Wires because they were packaged with the wrong internal component.

    Product
    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0098-2014·2013-11-06

    Small Bone Innovations Recalls Radial and Ulnar Stem Implants

    Small Bone Innovations is recalling 2,036 radial and ulnar stem implants due to a risk of sterile packaging breach.

    Product
    Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma C
    Category
    Medical Device
    Distribution
    Distributed nationwide