NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0823-2022.
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0823-2022.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0823-2022.
Ace Surgical Supply Co., Inc.
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The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Ace Surgical Supply Co., Inc. Recall FAQ
Ace Surgical Supply Co., Inc. is the subject of a medical devices safety report: NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250. The notice was published on February 2, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 31 units are potentially affected.