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U.S. Department of Health and Human Services

Class 2 Device Recall Interpore Cross International

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 Class 2 Device Recall Interpore Cross Internationalsee related information
Date Initiated by FirmNovember 07, 2003
Date PostedDecember 11, 2003
Recall Status1 Terminated 3 on April 20, 2004
Recall NumberZ-0211-04
Recall Event ID 27724
Product Classification Antiserum, Digoxin - Product Code DKA
ProductC-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
FEI Number 1000160576
Recalling Firm/
Manufacturer		 Interpore Cross International Inc
181 Technology Dr
Irvine CA 92618-2402
For Additional Information ContactCarol C. Berard
800-772-4489
Manufacturer Reason
for Recall		Step drills from Lot 25947 may have been mis-etched.
FDA Determined
Cause 2		Other
ActionThe consignees will be notified by letter.
Quantity in Commerce433 units
DistributionU.S., Netherlands, Australia, Venezuela, Mexico, Columbia and Brazil
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.
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