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

Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA. Intended to promote fusion of the cervical spine and occipitothoracic junction.

FDA Recall Z-1144-2010 · Posted 2010-03-16

Recalling FirmBlackstone Medical, Inc.
Recall StatusTerminated
Product CodeMNI
Date Initiated2010-02-02
Date Terminated2010-04-09
Product Quantity25

Reason for Recall

The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.

Firm Action

Orthofix Spinal Implants contacted customers by phone beginning December 22, 2009 and issued a Notification of Product Removal dated February 2, 2010. Consignees were instructed to Identify, Remove and Return all affected product to the firm. For further information, contact Orthofix Spinal Implants, Regulatory Affairs Department at 1-973-406-2812.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030197BLACKSTONE POSTERIOR CERVICAL SYSTEMBlackstone Medical, Inc. · 2003-06-12

Official Source

View FDA Recall →

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

↑