12 results
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47ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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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 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·February 20, 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 07/12/2012 an additional expired product was discovered by a Bacterin sales rep. B100078-908 with expiration date 04/27/2012
FDA Recall
Terminated
·Bacterin International, Inc.·Product code MBP·April 18, 2012
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 also used to insert the OsteoSponge SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.
FDA Recall
Terminated
·Bacterin International, Inc.·Product code LXH·March 9, 2015
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 to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
FDA Recall
Terminated
·Bacterin International, Inc.·Product code OEI·May 15, 2014
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
FDA Recall
Terminated
·Bacterin International, Inc.·Product code MBP·February 21, 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.
FDA Recall
Terminated
·Bacterin International, Inc.·Product code OEI·January 28, 2013
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 to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·June 11, 2014
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·April 24, 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.
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·March 20, 2013
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 also used to insert the OsteoSponge¿ SC graft during surgery. Such procedures include, but are not limited to, subchondral bone repair. Affected Part numbers are 6508 and 6511.
FDA Enforcement
Class II
·Terminated·Bacterin International, Inc.·April 15, 2015
MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B1025-104, B1025-105, B1025-106, B1025-107, B1025-108, B1025-109, B1025-112, and B1027-101
FDA Recall
Terminated
·Siemens Microscan·Product code JWY·July 31, 2008
MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers B1016-100, B1016-101, B1016-102, B1016-105, B1016-107, B1016-108, B1016-109, B1016-119, B1016-120, B1016-121, B1016-122, B1016-126, B1016-127, B1016-128, B1016-129, B1016-131, B1016-132, B1016-61a, B1016-62a, B1016-64a, B1016-65a, B1016-80, B1016-82, B1017-300, B1017-301, B1017-302, B1017-303, B1017-304, B1017-305, B1017-306, B1017-307, B1017-308, B1017-309, B1017-312, B1017-313, B1017-315, B1017-400, B1017-401, B1017-402, B1017-403, B1017-404, B1017-405, B1017-406, B1017-407, J1016-311c, J1016-312c, J1016-611c, J1016-611j, J1016-612b, J1016-612J, J1016-632J, J1016-623m, J1016-631J, J1016-632J, J1016-65c, J1016-66J, J1025-311, J1025-312, J1025-333, and J1025-611
FDA Recall
Terminated
·Siemens Microscan·Product code LON·July 31, 2008