NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250
Check against the official notice below — it lists the full affected range.
Ace Surgical Supply Co., Inc. is recalling NuOss Collagen Block (Catalog Number 5099250) used in filling periodontal and maxillofacial defects. The product in Lot Number BMBU21A1 with an expiration date of March 31, 2024 was incorrectly packaged with Collatene Fibrillar Collagen, which is intended for oral wounds rather than the correct NuOss Collagen Block. This packaging error may result in suboptimal bone repair in patients who received the wrong product. Thirty-one units were affected and distributed worldwide, including across the United States in Georgia, New York, Virginia, and Wisconsin, as well as in France and Germany.
The source document does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair
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. Quantity: 31 eaches Lot/code info: Lot Number: BMBU21A1 Exp. Date: 2024-03-31 UDI: 00614950007264
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.