Ascent Posterior Occipital Cervical Thoracic System, Single Looped Cable with Two Crimps, One Each. Distributed by Black
FDA device recall Z-1144-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Blackstone Medical, Inc.
- 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.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 25
- Distribution
- Worldwide Distribution -- United States (Texas and California), Australia, Colombia and Greece.
- Date initiated
- 2010-02-02
- Date posted
- 2010-03-16
- Date terminated
- 2010-04-09
- Location
- Wayne, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BLACKSTONE POSTERIOR CERVICAL SYSTEM (K030197) | Blackstone Medical, Inc. | 2003-06-12 |