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OPTEFORM RT Moldable Allograft of varying sizes. Product… recallZ-0484-06 · 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-0484-06
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

OPTEFORM RT Moldable Allograft of 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 (1k characters)

2613431 2613432 2613433 2613434 2613435 2613436 2613437 2613438 2613439 2613440 2613901 2613902 2613903 2613904 2613905 2613906 2613907 2614881 2614882 2614883 2614884 2614885 2614886 2614887 2614888 2614889 2614890 2653106 2653107 2653108 2654250 2654251 2654252 2654253 2654254 2654255 2654256 2654257 2654258 2654259 2699840 2699841 2699842 2699843 2485231 2485232 2485233 2485234 2485235 2485236 2485237 2485238 2485239 2485240 2595521 2595522 2595921 2595922 2595923 2595924 2595925 2595926 2595927 2595928 2595929 2595930 2978531 2978532 2978533 2978534 2978535 2978536 2978537 2978538 2978539 2978540 2983613 2983614 2983615 2983616 2983831 2983832 2983842 2983843 2983844 2984801 2984802 2984803 2984804 2984805 2984806 2984807 2984808 2984809 2984810 2985721 2985722 2985723 2985724 2985725 2985726 2985727 2985728 2985729 2985730 2985791 2985792 2985793 2985794 2985795 2985796 2985797 2985798 2985799 2985800 2985911 2985912 2985913 2985914 2985915 2985916 2985917 2985918 2985919 2985920 2985991 2985992 2985993 2985994 2985995 2985996 2985997 2985998 2985999 2986000 2986841 2986842 2986843 2986844 2986845 2986846 2986847 2986848 2986849 2986850 2986861 2986862 2986863 2986864 2986865 2986866 2986867 2986868 2986869 2986870 2987907 2987908 2999921 2999922 2999923

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