Food, drugs, devices › Bacterin International, Inc.
Device recall: Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfad
Bacterin International, Inc. (Belgrade, MT) initiated this device recall on 28 Jan 2013; FDA lists 1 product record under event 64326, 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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 8 Jul 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
"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 USA that received marketing samples. Plus 4 Bacterin representives nationwide…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0936-2013 | 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. | 15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee | Class II | Terminated | 20 Mar 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 |
| 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: "A portion of a silicone wound drain was found to be cracked."
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: "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…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Jul 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.