| Date Initiated by Firm | May 21, 2009 |
|---|
| Date Posted | July 06, 2009 |
|---|
| Recall Status1 |
Terminated 3 on April 07, 2015 |
| Recall Number | Z-1655-2009 |
|---|
| Recall Event ID |
52051 |
| 510(K)Number | K042514 |
|---|
| Product Classification |
spinal implants - Product Code MNI
|
| Product | Blackstone Medical:
ICON Modular Pedicle Screw System;
P/N's 54-9011 (implant set), 54-9020 (instrument case# I), 54-9030 (instrument case #2), spinal implants. |
|---|
| Code Information |
All lots |
| FEI Number |
3001238051
|
Recalling Firm/
Manufacturer |
Blackstone Medical, Inc.
1211 Hamburg Tpke
Suite 300
Wayne
NJ
07470
|
| For Additional Information Contact | SAME
413-731-8711 |
|---|
Manufacturer Reason
for Recall | Product marketed without an approved 510(k) |
|---|
FDA Determined
Cause 2 | Finished device change control |
|---|
| Action | Blackstone issued the recall notice to distributors by FedEx and email on May 21, 2009. This notification provides instructions to the field representatives how to return the product to Blackstone Medical. The Dear Doctor (Surgeon) letters are being sent Tues, May 26, 2009. |
|---|
| Quantity in Commerce | 63 implant kits, 80 instrument kits |
|---|
| Distribution | Nationwide |
|---|
| 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 = MNI
|
|---|
