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.
This recall has been terminated (originally issued March 16, 2010).
- Company
- Blackstone Medical, Inc.
- Recall Initiated
- February 2, 2010
- Posted
- March 16, 2010
- Terminated
- April 9, 2010
- Recall Number
- Z-1144-2010
- Quantity
- 25
- Firm Location
- Wayne, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.
Lot / Code Info
Part Number: 65-2053, Lot Number: 047247.
Root Cause
Labeling mix-ups
Action Taken
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.
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