Date Initiated by Firm |
May 16, 2005 |
Date Posted |
September 21, 2005 |
Recall Status1 |
Terminated 3 on December 02, 2005 |
Recall Number |
Z-1554-05 |
Recall Event ID |
32212 |
Product Classification |
Orthosis, Spondylolisthesis Spinal Fixation - Product Code MNH
|
Product |
The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis. |
Code Information |
Catalog No: 48905110 Lot Code: 039524; 039981; 045152; 045153; 045154; 045155; 045156; 045157; 045158; 045159; 048721; 048722. |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2002
|
For Additional Information Contact |
Dominick Cristofolo 201-831-5247
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Manufacturer Reason for Recall |
The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
|
FDA Determined Cause 2 |
Other |
Action |
The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt. |
Quantity in Commerce |
107 |
Distribution |
Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility. There are 31 branches and 1 hospital involved. |
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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