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 Interpore Cross International

  • 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 Interpore Cross International see related information
Date Initiated by Firm November 07, 2003
Date Posted December 11, 2003
Recall Status1 Terminated 3 on April 20, 2004
Recall Number Z-0211-04
Recall Event ID 27724
Product Classification Antiserum, Digoxin - Product Code DKA
Product C-Tek Anterior Cervical Plate System: 2.3mm/4.0mm Step Drill-14mm & 2.3mm/4.0mm Step Drill-16mm
Code Information Lot #25947 Catalog # 1100-9019 & #1100-9020
Recalling Firm/
Manufacturer		 Interpore Cross International Inc
181 Technology Dr
Irvine CA 92618-2402
For Additional Information Contact Carol C. Berard
800-772-4489
Manufacturer Reason
for Recall		 Step drills from Lot 25947 may have been mis-etched.
FDA Determined
Cause 2		 Other
Action The consignees will be notified by letter.
Quantity in Commerce 433 units
Distribution U.S., Netherlands, Australia, Venezuela, Mexico, Columbia and Brazil
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.
-
-