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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmFebruary 07, 2003
Date PostedMarch 20, 2003
Recall Status1 Terminated 3 on August 28, 2003
Recall NumberZ-0659-03
Recall Event ID 25628
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
ProductTPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.
Code Information Lot 32688
FEI Number 1000160576
Recalling Firm/
Manufacturer		 Interpore Cross International Inc
181 Technology Drive
Irvine CA 92618
For Additional Information ContactProssie Rey-Fessler
949-453-3200 Ext. 268
Manufacturer Reason
for Recall		Instrument fell apart during cleaning prior to surgery.
FDA Determined
Cause 2		Other
ActionFirm telephoned customers on 2/7/2003 requesting that they immediately return thier instruments.
Quantity in Commerce37 units
DistributionStates 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 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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