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Regeneration Technologies, Inc.

United StatesFDA applicant, unverified

Devices
11
FDA recalls
27

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue11

Newest first, rows 1-11 of 11

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Rows 1-11 of 11

FDA recalls27

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Showing the 10 most recent of 27 recalls.

  • 2005

    • 14 Oct 2005 Z-0481-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0482-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0483-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0484-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0485-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0486-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide.
    • 14 Oct 2005 Z-0487-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0488-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0489-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0490-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
Show the 25 most recent of 27 recalls

  • 2005

    • 14 Oct 2005 Z-0491-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0492-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0493-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0494-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0495-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0496-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0497-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0498-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0499-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0500-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043420
    • 14 Oct 2005 Z-0501-06 Unclassified (pre-2012) Terminated 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. Distribution: Products were distributed worldwide. Submission number: K043421
    • 14 Oct 2005 Z-0698-06 Unclassified (pre-2012) Terminated 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. Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
    • 14 Oct 2005 Z-0699-06 Unclassified (pre-2012) Terminated 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. Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
    • 14 Oct 2005 Z-0700-06 Unclassified (pre-2012) Terminated 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. Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.
    • 14 Oct 2005 Z-0701-06 Unclassified (pre-2012) Terminated 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. Distribution: Spinal Graft Technologies, Inc. 4340 Swinnea Rd, Ste 39, Memphis, TN 38118.

Frequently asked questions

How many devices does Regeneration Technologies, Inc. have in the registry?

The registry currently lists 11 devices for Regeneration Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Regeneration Technologies, Inc.'s devices?

Among its 11 most recently registered devices, Regeneration Technologies, Inc. has devices listed in FDA 510(k) (11 devices).

What risk classes do Regeneration Technologies, Inc.'s devices fall under?

Among its 11 most recently registered devices, the classes recorded for Regeneration Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Regeneration Technologies, Inc.?

FDA recall records list 27 recalls initiated by Regeneration Technologies, Inc., the most recent initiated on 14 Oct 2005. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Regeneration Technologies, Inc. in the registry?

The most recently registered devices listed for Regeneration Technologies, Inc. include STERLING INTERFERENCE SCREW ST, OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC, REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST and STERLING IF SCREW EYELET, MODEL CID3936 AND STERLING CROSS-PIN EYELET, MODEL CID3937.

Generated automatically from registry data and not verified by a human reviewer.