Recall Z-1608-2011 ยท NKB Thoracolumbosacral Pedicle Screw System
Orthofix Inc
ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18. Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. During assembly of a construct, the Anti-Splay Cap locks onto the Screw Body to prevent the Screw Body tabs from splaying (spreading apart). The Anti-Splay Cap is subsequently removed from the Screw Body
| Date | Mar 8, 2011 (initiated Oct 22, 2010) |
| Status | Terminated |
| Reason | There is a possibility that certain Anti-Splay Caps may not mate properly during assembly of the construct to the Screw Body with Multi-Axial Reduction Screw Assemblies. |
| Root cause | Other |
| Action | The firm, Orthofix, sent an "URGENT: PRODUCT RECALL" letter dated October 22, 2010 to all customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to: 1) identify and remove the affected product 2) complete the enclosed Tracking and Verification Form via fax to: Orthofix Inc. at 214-937-2764, and 3) contact their Account Services Representative at 1-888-298-5700 and obtain a return authorization number to return product to Orthofix, Inc. The letter also states that Orthofix Inc., will provide replacement Anti-Splay C |
| Quantity | 166 Units |
| Distribution | Nationwide distribution: USA including states of: CA, CO, FL, LA , MD, MI, MO, NJ, NY, OH, TN, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081684 | BLACKSTONE PEDICLE SCREW SYSTEM Blackstone Medical, Inc., Sep 15, 2008 |