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U.S. Department of Health and Human Services

Class 2 Device Recall Nexus or Geo

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 Class 2 Device Recall Nexus or Geosee related information
Date Initiated by FirmJanuary 14, 2005
Date PostedFebruary 04, 2005
Recall Status1 Terminated 3 on March 03, 2005
Recall NumberZ-0530-05
Recall Event ID 30997
510(K)NumberK040168 
Product Classification Spinal Vertebral Body Replacement Device - Product Code MQP
ProductSpinal Implant, Catalog number: 1000-3000 through 1000-3015 (9 catalog numbers)
Code Information NEXUS Product List Of Catalog Numbers & Lot Numbers     Catalog Number Lot Number/s 1000-3000 300510  303512A  302909A  303012  302812A  302912  302109  303009 1000-3001 326408A  304009  304509 1000-3003 301210  305809A  305509  304709A  305109  324508 1000-3004 304011A  310110  303911A 1000-3005 304211A  312410  301112  304311 1000-3010 302407  300404 1000-3011 313207 1000-3013 307404  312107  312307A 1000-3015 306911A  309505  305605  305905  307111 
FEI Number 1000160576
Recalling Firm/
Manufacturer		 Interpore Cross International Inc
181 Technology Dr
Irvine CA 92618-2402
For Additional Information ContactProsie Fessler
949-453-3200 Ext. 268
Manufacturer Reason
for Recall		Mislabeled.
FDA Determined
Cause 2		Other
ActionFirm sent recall letters on 1/18/2005 requesting return of product. A response form was enclosed.
Quantity in Commerce63
DistributionTN, MT, MI, CA, IN, PA, NJ, TX, KY, LA, CO.
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.
510(K) Database510(K)s with Product Code = MQP
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