FDA product code OJZ: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde

OJZ is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde. It is a HDE device, reviewed by the Orthopedic panel. Devices under OJZ reach the market by Unclassified; FDA lists no cleared 510(k)s for it. FDA has posted 1 recall for OJZ devices.

Definition

Device type: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest. Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics. Revision spine surgery to treat pseudarthrosis.

Classification

Recalls for OJZ devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-10-25.

Frequently asked questions

What is FDA product code OJZ?

OJZ is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde. It is a HDE device, reviewed by the Orthopedic panel.

What device class is OJZ?

HDE. Typical premarket route: Unclassified.

Have OJZ devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2010-10-25.

Next steps

• Run an FDA pathway report with predicate devices for product code OJZ
• Run a recall and safety report across every OJZ manufacturer
• Watch product code OJZ for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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