Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to u
FDA device recall Z-1479-2008 · posted 2008-07-23 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)
- Action taken
- The recalling firm notified sales reps regarding the recall by phone on 02/13/08. The sales reps were instructed to discontinue kit use in surgeries and to return inventory. Surgeons who had used the Sequoia System in surgery were notified of the recall via letter on 02/20/08. Surgeons were asked to monitor for post-operative dissociation in implanted patients and to notify Abbott Spine sales reps if any incidences occur.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 38 surgical kits.
- Distribution
- Nationwide Distribution including states of AR, AZ, CA, CT, CO, FL, IL, MD, MI, MN, NC, OH, OK, OR, PA, TX, VA and WI.
- Date initiated
- 2008-02-13
- Date posted
- 2008-07-23
- Date terminated
- 2008-07-28
- Location
- Austin, TX
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 3300 SERIES (K072672) | Abbott Spine, Inc. | 2007-11-28 |