Recall Z-0554-2010 ยท NKB Thoracolumbosacral Pedicle Screw System
Zimmer Inc.
Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system.
| Date | Dec 22, 2009 (initiated Aug 20, 2009) |
| Status | Terminated |
| Reason | The tip of the instrument may fracture during use. |
| Root cause | Device Design |
| Action | Zimmer sent a letter dated 8/17/09 to distributors and consignees on or about 8/20/09. Users were notified of the potential problem via the letter and advised that the instruments will be removed and replaced when a new version of the instrument becomes available (around 10/09). |
| Quantity | 215 |
| Distribution | Nationwide, Belgium and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) Abbott Spine, Inc., Oct 6, 2008 |