ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICO
FDA device recall Z-0716-06 · posted 2006-04-19 · Terminated
Recall details
- Recalling firm
- Blackstone Medical Inc.
- Reason for recall
- Pedicle Screw may disengage in post op period requiring intervention
- Action taken
- Blackstone Medical notified Distributors by email on 12/23/05 to quarantine inventory. A letter notifying physicans was issued 12/28/05 via Fed''X. Product is to be returned to Blackstone Medical.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 23 sets
- Distribution
- AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany
- Date initiated
- 2005-12-23
- Date posted
- 2006-04-19
- Date terminated
- 2013-04-09
- Location
- Springfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM (K042514) | Blackstone Medical, Inc. | 2004-10-07 |