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

  • 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 see related information
Date Initiated by Firm February 07, 2003
Date Posted March 20, 2003
Recall Status1 Terminated 3 on August 28, 2003
Recall Number Z-0659-03
Recall Event ID 25628
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.
Code Information Lot 32688
Recalling Firm/
Manufacturer		 Interpore Cross International Inc
181 Technology Drive
Irvine CA 92618
For Additional Information Contact Prossie Rey-Fessler
949-453-3200 Ext. 268
Manufacturer Reason
for Recall		 Instrument fell apart during cleaning prior to surgery.
FDA Determined
Cause 2		 Other
Action Firm telephoned customers on 2/7/2003 requesting that they immediately return thier instruments.
Quantity in Commerce 37 units
Distribution States of NJ, CA, PA, MN, WI, MO, FL, OH, VA, MD, Wash DC, NY, CO, MA and to Brazil, Mexico, England, Denmark, Belgium, Australia.
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.
-
-