Date Initiated by Firm |
January 17, 2003 |
Date Posted |
February 21, 2003 |
Recall Status1 |
Terminated 3 on May 28, 2003 |
Recall Number |
Z-0559-03 |
Recall Event ID |
25421 |
Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
|
Product |
Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001. |
Code Information |
Lot numbers P010900 and P010957 |
Recalling Firm/ Manufacturer |
Sulzer Spine-Tech 7375 Bush Lake Road Minneapolis MN 55439-2027
|
Manufacturer Reason for Recall |
With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip.
|
FDA Determined Cause 2 |
Other |
Action |
The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product. |
Quantity in Commerce |
14 instruments |
Distribution |
The instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives. |
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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