Food, drugs, devices › Bacterin International, Inc.
Device recall: Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5c
Bacterin International, Inc. (Belgrade, MT) initiated this device recall on 18 Apr 2012; FDA lists 1 product record under event 63433, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 13 May 2013. Initiation: voluntary: firm initiated. Bacterin International, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Bacterin International, Inc., Belgrade, MT.
Reason for recall
"Expired product was shipped to two customers."
Distribution
"Nationwide Distribution in TX , GA and CA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0800-2013 | 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… | 3 packages each containing 2.5cc of putty | Class II | Terminated | 20 Feb 2013 |
Context
Other enforcement events for Bacterin International, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Mar 2015 | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bo | Device | Class II | 1 |
| 15 May 2014 | Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 un | Device | Class II | 1 |
| 21 Feb 2013 | OsteoSelect DBM Putty Product Usage: Orthopedic bone filler | Device | Class II | 1 |
| 28 Jan 2013 | Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfad | Device | Class II | 1 |
All 5 events for Bacterin International, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Expired product was shipped to two customers."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution in TX , GA and CA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 May 2013. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.