| Date Initiated by Firm | December 23, 2005 |
|---|
| Date Posted | April 19, 2006 |
|---|
| Recall Status1 |
Terminated 3 on April 09, 2013 |
| Recall Number | Z-0716-06 |
|---|
| Recall Event ID |
34355 |
| 510(K)Number | K042514 |
|---|
| Product Classification |
Appliance, Fixation, Spinal Intervertebral Body - Product Code KWQ
|
| Product | 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 |
|---|
| Code Information |
All lots |
| FEI Number |
3001238051
|
Recalling Firm/
Manufacturer |
Blackstone Medical Inc.
90 Brookdale Drive
Springfield
MA
01104-3206
|
| For Additional Information Contact | Diane M Johnson
410-709-8276 |
|---|
Manufacturer Reason
for Recall | Pedicle Screw may disengage in post op period requiring intervention |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 23 sets |
|---|
| Distribution | AL,CA, CO, IL, NH, NM, TX
Foreign: BMI , Diessen, Germany |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = KWQ
|
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