Recall Register

Food, drugs, devices › Firms

Bacterin International, Inc.

FDA recalling firm · 5 enforcement events · 5 product records · 2012–2015 · MT

Bacterin International, Inc. has 5 FDA enforcement events on this register (5 product records) between 2012 and 2015: 5 device; the busiest year was 2013 with 2.

0% of its events are Class I; the most common class is Class II (5). 0 events are listed as ongoing; the recalling firm's address is in MT.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
9 Mar 2015Instrument 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…DeviceClass II1Terminated
15 May 2014Wound 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…DeviceClass II1Terminated
21 Feb 2013OsteoSelect DBM Putty Product Usage: Orthopedic bone fillerDeviceClass II1Terminated
28 Jan 2013Bacterin 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.DeviceClass II1Terminated
18 Apr 2012Bacterin 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…DeviceClass II1Terminated

By type and class

Device5
Class II5

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

12
14
16
18
20
22
24
26
Enforcement events for Bacterin International, Inc. by year initiated.

Questions and answers

How many FDA recalls has Bacterin International, Inc. had?

5 enforcement events (5 product records) on this register, 2012–2015: 5 device.

Are any Bacterin International, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Bacterin International, Inc. recalls?

5 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.