Zimmer / Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle sc
FDA device recall Z-0554-2010 · posted 2009-12-22 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The tip of the instrument may fracture during use.
- Action taken
- 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).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 215
- Distribution
- Nationwide, Belgium and New Zealand.
- Date initiated
- 2009-08-20
- Date posted
- 2009-12-22
- Date terminated
- 2011-04-13
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) (K082032) | Abbott Spine, Inc. | 2008-10-06 |