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Bacterin International Recalls
5 recalls on record · February 20, 2013 to April 15, 2015 · Medical Devices
Recalls by year
13
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 15, 2015Medical DevicesFDA
Bacterin International, Inc. recalls Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill b
Hazard: 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.
June 11, 2014Medical DevicesFDA
Bacterin International, Inc. recalls Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 u
Hazard: The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized
April 24, 2013Medical DevicesFDA
Bacterin International, Inc. recalls OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Hazard: The firm's retesting procedure was not validated.
March 20, 2013Medical DevicesFDA
Bacterin International, Inc. recalls Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfad
Hazard: A portion of a silicone wound drain was found to be cracked.
February 20, 2013Medical DevicesFDA
Bacterin International, Inc. recalls Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5
Hazard: Expired product was shipped to two customers.