Date Initiated by Firm |
January 20, 2003 |
Date Posted |
February 26, 2003 |
Recall Status1 |
Terminated 3 on May 06, 2003 |
Recall Number |
Z-0582-03 |
Recall Event ID |
25585 |
Product Classification |
Bit, Drill - Product Code HTW
|
Product |
T2 3.5x130mm AO Drill Bit |
Code Information |
1806-3550S T2 3.5x130mm AO Drill Bit -- K561203; K569685; K569686; K591212; K591213; K653373; K713876; K725975; K743641; K743642. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics 300 Commerce Court Mahwah NJ 07430
|
For Additional Information Contact |
Thomas Grzeskowiak 201-831-5495
|
Manufacturer Reason for Recall |
Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
|
FDA Determined Cause 2 |
Other |
Action |
Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts. |
Quantity in Commerce |
290 |
Distribution |
Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation. |
Total Product Life Cycle |
TPLC Device Report
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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.
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