FDA recall Z-0823-2022

Ace Surgical Supply Co., Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

Worldwide distribution - US Nationwide distribution in the states of GA, NY, VA, WI and the countries of France, Germany.

Key facts

Status: Ongoing
Initiation date: 2022-02-02
Report date: 2022-03-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brockton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0823-2022