Food, drugs, devices › Bacterin International, Inc.
Device recall: Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bo
FDA enforcement event 70744 is a device recall by Bacterin International, Inc. of Belgrade, MT, initiated 9 Mar 2015 and classified Class II, with 1 product record.
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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 1 Jul 2015. 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
"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, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1396-2015 | 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… | 63 units | Class II | Terminated | 15 Apr 2015 |
Context
Other enforcement events for Bacterin International, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 18 Apr 2012 | Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5c | 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: "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."
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: "US Distribution in states of: Alabama, Arizona, Arkansas, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 1 Jul 2015. "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.