Bacterin International, Inc.: FDA recalls

FDA enforcement events from 2012 to 2015; export dated 3 Nov 2026. The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Bacterin International, Inc. as the recalling firm in 5 events. The events have 5 product records. The recalls started from 2012 to 2015. All the events are device recalls. By FDA enforcement events, Bacterin International, Inc. is number 679 of 1,628 firms that have a page. Events that Bacterin International, Inc. started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

See the 5 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 3 Nov 2026.

Enforcement events

5 events, newest first.

FDA enforcement events of Bacterin International, Inc.
Initiated	Product (first record)	Type	Class	Records	Status
9 Mar 2015	Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is…	Device	Class II	1	Terminated
15 May 2014	Wound Drain - Label reads in part "Elutia *Hubless Coated Silicone Surgical Wound Drain*" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or…	Device	Class II	1	Terminated
21 Feb 2013	OsteoSelect DBM Putty Product Usage: Orthopedic bone filler	Device	Class II	1	Terminated
28 Jan 2013	Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.	Device	Class II	1	Terminated
18 Apr 2012	Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of surgically created osseous defects. On…	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Bacterin International, Inc.: events for each product type
Type		Events
Device		5

Bacterin International, Inc.: events in each class
Class		Events
Class II		5

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Bacterin International, Inc., by the year that the recall started. The largest year is 2013, with 2 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Bacterin International, Inc.: FDA recalls. https://recallregister.com/firm/bacterin-international-inc/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
State of the firm address: MT

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Bacterin International, Inc. have?: Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Bacterin International, Inc.?: FDA event 70744, which the firm started on 9 Mar 2015. The first product in the record is: Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open procedure. The kit is…
How many FDA recalls of Bacterin International, Inc. have the status Ongoing?: No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.