Recall Z-0823-2022— Ace Surgical Supply Co., Inc.

Name: FDA recall Z-0823-2022
Creator: U.S. Food and Drug Administration
Published: 2022-02-02

Class II · Ongoing

Class II FDA medical device recall by Ace Surgical Supply Co., Inc., initiated 2022-02-02. It names one FDA 510(k) clearance: K043034. Product: NuOss Collagen Block Size 8mm x 9mm x 9mm- used in filling periodontal and maxillofacial defects. Catalog Number: 5099250. Reason: NuOss Collagen (dental) was packaged with a Collatene Fibrillar Collagen(for oral wounds) rather than NuOss Collagen Block, may result in suboptimal bone repair.

Recalling firm: Ace Surgical Supply Co., Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-02-02
Firm location: Brockton, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K043034 — OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTSCollagen Matrix, Inc.·cleared 2005-08-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.