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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm October 14, 2005
Date Posted February 07, 2006
Recall Status1 Terminated 3 on July 26, 2012
Recall Number Z-0483-06
Recall Event ID 34004
510(K)Number K043421  
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Product is OPTEFORM Allograft Paste of varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.
Code Information 3043561 3043562 3043563 3043564 3043565 3043566 3043567 3043568 3043569 3043570 3047041 3047042 3047043 3051158 3051159 3051160 3051193 3051194 3051195 3051196 3051197 3051198 3051199 3051491 3051493 3051495 3051497 3050703 3050705 3050706 3050710 3056760 3060591 3027677 3027678 3027679 3044581 3044582 3044583 3044584 3044585 3044586 3044587 3044588 3044589 3044590 3044931 3044932 3044933 3044934 3044935 3044936 3044937 3044938 3044939 3044940 3044941 3044942 3044943 3044944 3044945 3044946 3044947 3044948 3044949 3044950 3045571 3045572 3045573 3045574 3045575 3045576 3045941 3045942 3045943 3045944 3045946 3045947 3045948 3045949 3046341 3046342 3046343 3046344 3046345 3046346 3046347 3046348 3046349 3046350 3046531 3046532 3046533 3046534 3046535 3046536 3046537 3046538 3046539 3046540 3046621 3046622 3046623 3046624 3046625 3046626 3046627 3046628 3046629 3046630 3046661 3046662 3046663 3046664 3046665 3046666 3046667 3046668 3046669 3046670 3046671 3046672 3046673 3046674 3046675 3046676 3046677 3046678 3046679 3046680 3046731 3046732 3046733 3046734 3046735 3046736 3046737 3046738 3046739 3046740 3046831 3046832 3046833 3046834 3046835 3046836 3046837 3046838 3046839 3046840 3046971 3046972 3046973 3046974 3046975 3046976 3046977 3046978 3046979 3046980 3046981 3046982 3046983 3046984 3046985 3046986 3046987 3046988 3046989 3046990 3047401 3047402 3047403 3047404 3047405 3047406 3047407 3047408 3047409 3047410 3051101 3051102 3051103 3051104 3051105 3051161 3051162 3051163 3051164 3051165 3051166 3051167 3051168 3051169 3051170 3051221 3051222 3051223 3051224 3051226 3051227 3051228 3051229 3051230 3051231 3051232 3051233 3051234 3051235 3051236 3051237 3051238 3051239 3051240 3051241 3051242 3051243 3051244 3051245 3051246 3051247 3051248 3051249 3051250 3051271 3051272 3051273 3051274 3051275 3051276 3051277 3051278 3051279 3051280 3051381 3051382 3051383 3051384 3051385 3051386 3051387 3051388 3051389 3051390 3051422 3051423 3051424 3051425 3051426 3051427 3060550 3060551 3060552 
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
Action Notification sent to all consignees by FedEx. 10/14/2005
Distribution Products were distributed worldwide.
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.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = REGENERATION TECHNOLOGIES, INC.
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