The Recall Desk

Manufacturer

Bacterin International, Inc.

5 recalls in our database name Bacterin International, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2015-04-15

Of the 5 recalls from Bacterin International, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–5 of 5

  • ModerateFDA (Devices)·Z-1396-2015·2015-04-15

    Bacterin OsteoSponge Instrument Kits Recalled for Sterilization Errors

    Bacterin International is recalling 63 Instrument Kits for OsteoSponge SC grafts because the instructions for use contain incorrect sterilization parameters.

    Product
    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 instrumen
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-1680-2014·2014-06-11

    Bacterin Elutia Wound Drains Recalled for Missing Dose Audits

    Bacterin International is recalling Elutia Hubless Coated Silicone Surgical Wound Drains because quarterly dose audits were omitted. The products were appropriately sterilized.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1138-2013·2013-04-24

    Bacterin OsteoSelect DBM Putty Recalled for Unvalidated Testing Procedure

    Bacterin International is recalling 165 units of OsteoSelect DBM Putty because the firm's retesting procedure was not validated.

    Product
    OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0936-2013·2013-03-20

    Bacterin Elutia Silicone Surgical Wound Drain Recalled for Cracks

    Bacterin International is recalling specific lots of Elutia silicone surgical wound drains because a portion of the drain was found to be cracked.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2013·2013-02-20

    Bacterin Recalls Expired Osteoselect Demineralized Bone Matrix Putty

    Bacterin International is recalling expired Osteoselect Demineralized Bone Matrix Putty shipped to customers in Texas, Georgia, and California.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide