TraXis Vue Spinal Implant System, Part #2601-090921
FDA device recall Z-0502-06 · posted 2006-02-07 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Implants were manufactured without radiographic markers.
- Action taken
- Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 41 units
- Distribution
- Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
- Date initiated
- 2005-11-02
- Date posted
- 2006-02-07
- Date terminated
- 2007-09-25
- 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 |
|---|---|---|
| SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM (K031855) | Spinal Concepts, Inc. | 2003-09-17 |