Recall Z-0716-06 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Blackstone Medical Inc.
ICON Modular Spinal Fixation System used with the: ICON Implant Case (containing Pedicle Screws) Item Number 54-1090 ICON Instrument Case 1 Item Number: 54-1091 ICON Instrument Case 2 Item Number: 54-1092
| Date | Apr 19, 2006 (initiated Dec 23, 2005) |
| Status | Terminated |
| Reason | Pedicle Screw may disengage in post op period requiring intervention |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 23 sets |
| Distribution | AL,CA, CO, IL, NH, NM, TX Foreign: BMI , Diessen, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042514 | MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM Blackstone Medical, Inc., Oct 7, 2004 |