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U.S. Department of Health and Human Services

Class 2 Device Recall SpineTech

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  Class 2 Device Recall SpineTech see related information
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
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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