Z-1144-2010

Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each...

Name: Z-1144-2010 Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each...
Creator: Blackstone Medical, Inc.
Published: 2010-02-02
License: https://open.fda.gov/license/

Blackstone Medical, Inc. / initiated 2010-02-02 / Terminated / root cause: labeling and UDI

FDA source

Blackstone Medical, Inc. began a recall of Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Blackstone Medical, Springfield, MA... on 2010-02-02. The reason FDA records is "The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1144-2010
Status: Terminated
Initiated: 2010-02-02
Posted: 2010-03-16
Terminated: 2010-04-09
Recalling firm: Blackstone Medical, Inc.
Product: 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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 25
Distribution: Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.
Product codes and lots: Part Number: 65-2053, Lot Number: 047247.

Product code MNI

K030197Class IIBlackstone Posterior Cervical SystemBlackstone Medical, Inc. / cleared 2003-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)