FDA Medical Device Recalls (openFDA)
Blackstone Medical, Inc.: 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.
- Recall number
- Z-1144-2010
- 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.
- Status
- Terminated
- Initiated
- 2010-02-02
- Posted
- 2010-03-16
- Terminated
- 2010-04-09
- Reason
- The Ascent Posterior Occipital Cervical Thoracic System Single Looped Cable with two crimps may be made of stainless steel instead of Titanium.
- 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
- 25
- Distribution
- Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.
- Lot, serial or model codes
- Part Number: 65-2053, Lot Number: 047247.
- 510(k) numbers
- ["K030197"]
- PMA numbers
- not on file
- Product code
- MNI
- Firm FEI
- 3001238051
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28