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Class 2 Device Recall OrthoTec |
 |
| Date Initiated by Firm |
November 12, 2003 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on May 03, 2004 |
| Recall Number |
Z-0171-04 |
| Recall Event ID |
27690 |
| Product Classification |
Tubing, Fluid Delivery - Product Code FPK
|
| Product |
Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000. |
| Code Information |
Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462. |
Recalling Firm/
Manufacturer |
Stryker Instruments, Instruments Div.
4100 E. Milham
Kalamazoo MI 49001
|
| For Additional Information Contact |
Becky Ditty
800-800-4236 Ext. 3434
|
Manufacturer Reason
for Recall |
Product sterility may have been compromised by an inadequate package seal.
|
FDA Determined
Cause 2 |
Other |
| Action |
Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product. |
| Quantity in Commerce |
15 |
| Distribution |
United States, France and United Kingdom. |
| 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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