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Bacterin International, Inc.

United StatesFDA applicant, unverified

Devices
4
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Bacterin International, Inc. makes

Bacterin International, Inc. makes demineralized bone matrix putty, such as OsteoSelect Demineralized Bone Matrix Putty and OsteoSelect PLUS Demineralized Bone Matrix Putty, as well as coated closed surgical wound drains like ELUTIA Coated Closed Surgical Wound Drain.

The company's portfolio is regulated as Class II devices and is listed in the FDA 510(k) registry. The company is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 5 recalls initiated by Bacterin International, Inc., the earliest on 2012-04-18 and the most recent on 2015-03-09. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 9 Mar 2015 Z-1396-2015 Class II Terminated Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Facet Dowel have incorrect sterilization parameters in the IFU and on the lid of the kits. Sterilization parameters for the Steam Gravity 121 degree C (250 F) cycle were not validated and the dry time for the Steam Pre-Vacuum 132 degree C (270 F) cycle was omitted. Distribution: US Distribution in states of: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana,…
      Full distribution text US Distribution in states of: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, and Virginia.

  • 2014

    • 15 May 2014 Z-1680-2014 Class II Terminated The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized Distribution: Distributed to one foreign consignee in Lebanon. Submission number: K063245

  • 2013

    • 21 Feb 2013 Z-1138-2013 Class II Terminated The firm's retesting procedure was not validated. Distribution: USA Nationwide Distribution Submission number: K091321
    • 28 Jan 2013 Z-0936-2013 Class II Terminated A portion of a silicone wound drain was found to be cracked. Distribution: 13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in…
      Full distribution text 13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
      Submission number: K063245

  • 2012

    • 18 Apr 2012 Z-0800-2013 Class II Terminated Expired product was shipped to two customers. Distribution: Nationwide Distribution in TX , GA and CA. Submission number: K091321

Frequently asked questions

How many devices does Bacterin International, Inc. have in the registry?

The registry currently lists 4 devices for Bacterin International, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bacterin International, Inc.'s devices?

Among its 4 most recently registered devices, Bacterin International, Inc. has devices listed in FDA 510(k) (4 devices).

What risk classes do Bacterin International, Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Bacterin International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Bacterin International, Inc.?

FDA recall records list 5 recalls initiated by Bacterin International, Inc., the most recent initiated on 9 Mar 2015. 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 Bacterin International, Inc. in the registry?

The most recently registered devices listed for Bacterin International, Inc. include OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY, ELUTIA COATED CLOSED SURGICAL WOUND DRAIN and OsteoSelect PLUS Demineralized Bone Matrix Putty.

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