Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall SpineTech

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall SpineTechsee related information
Date Initiated by FirmJanuary 17, 2003
Date PostedFebruary 21, 2003
Recall Status1 Terminated 3 on May 28, 2003
Recall NumberZ-0559-03
Recall Event ID 25421
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
ProductSpine-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
FEI Number 1000115775
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
ActionThe firm sent a letter, dated January 17, 2003, which requested that the consignees return the product.
Quantity in Commerce14 instruments
DistributionThe instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives.
Total Product Life CycleTPLC 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.
-
-