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U.S. Department of Health and Human Services

Class 3 Device Recall Osteofil ICM Moldable Strip

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 Class 3 Device Recall Osteofil ICM Moldable Stripsee related information
Date Initiated by FirmOctober 14, 2005
Date PostedMarch 28, 2006
Recall Status1 Terminated 3 on August 07, 2012
Recall NumberZ-0702-06
Recall Event ID 34367
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
ProductOsteofil ICM Moldable Strip of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 1662221 1662222 1662224 1662225 1662226 1662228 1662229 1662230 1672261 1672262 1672263 1672264 1672265 1672266 1672267 1672268 1672269 1672270 2085436 2091131 2091132 2091133 2091135 2091136 2091137 2091138 2091140 2094702 2094703 2094704 2094705 2094706 2094709 2207921 2207922 2207925 2207926 2207927 2207930 2724041 2724042 2724043 2724045 2724048 1662223 2091134 2091139 2094701 2094707 2094708 2094710 2207923 2207924 2207928 2207929 2724040 2724044 2724046 2724047 2193437 2193438 2193439 2197304 2197305 2197307 2197308 2197309 2197310 2197311 2197313 2290771 2290772 2290774 2290775 2290776 2290777 2290778 2290779 2290780 2291312 2291313 2291314 2291315 2291316 2291317 2291319 2291320 2774214 2774217 2774218 2193436 2197306 2197312 2290773 2291311 2291318 2774213 2774215 2774216 
FEI Number 3002719998
Recalling Firm/
Manufacturer		 Regeneration Technologies, Inc.
11621 Research Circle
Alachua FL 32615
Manufacturer Reason
for Recall		The tissue was collected from donors for whom there is no verifiable identity or consent. The medical records and social histories of the donors cannot be ascertained. The devices which incorporate these donor bone tissues undergo processing, including sterilization, which has been validated to inactivate and/or remove all viral diseases for which human tissue donors are tested.
FDA Determined
Cause 2		Other
ActionNotification sent to all consignees by Fed Ex 10/14/2005.
Quantity in Commerce99
DistributionSpinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
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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