Date Initiated by Firm |
August 18, 2003 |
Date Posted |
August 27, 2003 |
Recall Status1 |
Terminated 3 on November 19, 2003 |
Recall Number |
Z-1183-03 |
Recall Event ID |
27014 |
510(K)Number |
K0202279 K031585
|
Product Classification |
Orthosis, Spinal Pedicle Fixation - Product Code MNI
|
Product |
Optima Large Poly Screw Driver |
Code Information |
Part Number OP20012 Revision B, Lot Numbers 04240301 and 04140302. |
Recalling Firm/ Manufacturer |
U&I America 6132 South 380 West - Suite 200 Murray UT 840434355
|
For Additional Information Contact |
801-262-3100
|
Manufacturer Reason for Recall |
Reports of pieces chipping off the tip of screwdriver during use.
|
FDA Determined Cause 2 |
Other |
Action |
Consignee was notified by letter on 8/18/2003 |
Quantity in Commerce |
116 units. |
Distribution |
MN |
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 and Original Applicant = U&I CORP., AMERICA
|