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Osteofil + RT Allograft Paste in varying sizes. Product is… recallZ-0485-06 · Regeneration Technologies, Inc. · initiated Oct 14, 2005

Terminated All recalls posted in February 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Regeneration Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Other

What the company is doing

Notification sent to all consignees by FedEx. 10/14/2005

Recall details

Recall number
Z-0485-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 14, 2005
Posted by the FDA
Feb 7, 2006
Recalling firm
Regeneration Technologies, Inc.
Product code
MQV
FDA submissions
K043421
Distribution
Products were distributed worldwide.

Product description

Osteofil + RT Allograft Paste in varying sizes. Product is labeled in part: ''***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, Florida USA***SINGLE PATIENT USE ONLY***''.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

2488121 2488122 2488123 2488124 2488125 2488126 2488127 2488128 2488130 2497251 2497252 2497253 2497253 2497254 2497255 2497256 2497257 2497258 2497259 2497260 2497361 2497362 2497363 2497364 2497365 2497366 2497367 2497368 2497369 2497370 2501782 2501783 2501784 2501785 2501786 2501787 2501788 2501789 2501790 2501791 2501791 2501832 2501833 2501834 2501835 2501836 2501837 2501838 2501839 2501840 2501841 2501872 2501873 2501874 2501875 2501876 2501877 2501878 2501879 2501880 2501881 2502191 2502192 2502193 2502194 2502195 2502196 2502197 2502198 2502199 2502200 2559851 2559852 2559853 2559854 2559855 2559856 2559857 2559858 2559859 2559951 2559952 2559953 2559954 2559955 2559956 2559957 2559958 2559959 2559960 2559991 2559992 2559993 2559994 2559995 2559996 2559997 2559998 2559999 2560000 2560071 2560072 2560073 2560074 2560075 2560076 2560077 2560078 2560079 2560080 2560221 2560222 2560223 2560224 2560225 2560226 2560227 2560228 2560229 2560230 2560273 2560274 2560275 2560276 2560277 2560278 2560279 2560280 2560471 2560472 2560473 2560474 2560475 2560476 2560477 2560478 2560479 2560480 2561641 2561642 2561643 2561645 2561646 2561647 2561648 2561649 2561650 2561841 2561842 2561843 2564571 2564572 2564573 2564574 2564575 2564576 2564577 2564578 2564579 2564580 2564591 2564592 2564593 2564594 2564595 2564596 2564598 2564599 2564600 2565581 2565582 2565583 2565584 2565585 2565586 2565587 2565588 2565589 2565971 2565972 2565973 2565974 2565975 2565976 2565977 2565978 2565979 2565980 2613351 2613352 2613353 2613354 2613355 2613356 2613358 2613359 2613461 2613462 2613463 2613465 2613466 2613467 2613468 2613469 2613470 2613524 2613525 2613526 2613527 2613528 2613529 2613908 2613909 2613910 2613931 2613932 2613933 2613934 2613935 2613936 2613937 2613938 2613939 2613940 2613971 2613972 2613974 2613975 2613976 2613977 2613978 2613979 2613980 2614371 2614372 2614373 2614374 2614375 2614376 2614377 2614551 2614552 2614553 2614554 2614555 2614556 2614558 2614591 2614592 2614593 2614594 2614595 2614596 2614597 2614599 2614891 2614892 2614893 2614894 2614895 2614896 2614899 2614900 2614982 2614984 2614989 2614990 2616221 2616222 2616223 2616224 2616227 2616228 2616229 2616230 2616491 2616492 2616493 2616494 2616495 2616496 2616497 2616500 2620221 2620223 2620225 2620227 2620229 2620271 2620272 2620276 2620277 2620278 2620279 2620280 2689161 2689163 2689165 2689166 2689168 2689169 2689371 2689372 2689373 2689374 2689375 2689376 2689378 2690294 2690295 2690297 2690299 2690300 2690301 2690303 2692921 2692922 2692923 2692926 2692927 2692928 2692929 2692939 2713197 2713198 2713199 2713200 2713202 2713203 2713228 2713230 2713231 2713232 2713234 2713235 2713236 2713388 2713389 2713390 2713391 2713392 2713393 2713394 2713395 2713396 2713427 2713428 2713429 2713430 2713431 2713433 2713434 2713435 2713436 2718753 2718754 2718755 2718756 2718758 2718760 2718791 2718793 2718794 2718795 2718796 2718798 2718800 2718931 2718932 2718934 2718935 2718936 2718937 2718940 2718961 2718962 2718965 2718969 2718970 1901774 1901775 1901776 1901777 1901778 1901779 1901780 1901781 1901782 1901783 1901804 1901805 1901806 1901807 1901808 1901809 1901810 1901811 1901812 1901813 1909226 1909227 1909228 2679851 2679852 2689260 2689261 2689262 2689263 2689264 2689265 2689266 2689267 2689268 2689269 2692940 2692941 2692942 2692943 2692944 2692945 2692946 2692947 2692948 2692949

Other devices under the same FDA submission

3 devices cleared under K043421 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 34004).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page