Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

NuOSS Cancellous Intended for use in dental surgery.

FDA Recall Z-1096-2016 · Posted None

Recalling FirmCollagen Matrix Inc
Recall StatusTerminated
Product CodeNPM
Date Initiated2015-08-25
Date Terminated2016-05-11
Product Quantity171 units

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.

Firm Action

Collagen Matrix Inc. notified their sole customer on November 17, 2015. On August 25, 2015, during a review of inventory, tt was discovered that of the 171 units product shipped, 19 units may have been the incorrect size. For further questions please call (201) 405-1477

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

US Distribution to the state of : MA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043034OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTSCollagen Matrix, Inc. · 2005-08-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑