Recall Z-1096-2016— Collagen Matrix Inc

Name: FDA recall Z-1096-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-25

Class II · Terminated

Class II FDA medical device recall by Collagen Matrix Inc, initiated 2015-08-25, terminated 2016-05-11. It names one FDA 510(k) clearance: K043034. Product: NuOSS Cancellous Intended for use in dental surgery.. Reason: On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size..

Recalling firm: Collagen Matrix Inc
Classification: Class II
Status: Terminated
Initiated: 2015-08-25
Terminated: 2016-05-11
Firm location: Franklin Lakes, NJ, 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 Cancellous Intended for use in dental surgery.

Reason for recall

On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.

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