Medical device recalls Moderate risk

Ace Surgical Supply Co., Inc. recalls NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 50992…

Recall date
February 2, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0823-2022
FDA classification
Class II
Brand / firm
Ace Surgical Supply Co., Inc.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.

Why it was recalled

NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250

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