41 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ
FDA 510(k)
FDA Class 2
·Orthopedic
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Recall
Open, Classified
·Exactech, Inc.·Product code JWH·August 30, 2021
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772813872·GENUMEDI PRO SILVER SIZE VII
Publix
FDA UDI
PUBLIX SUPER MARKETS, INC.·00041415028746·PUB LATEX MED EXAM GLOVES
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515064522·Mayo Hegar NH, 8"
Cervical Interbody 13mm x 12mm x 7mm Packaging
FDA UDI
XENCO MEDICAL LLC·B064XM11213071·Cervical Interbody 13mm x 12mm x 7mm
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515016545·Mayo Hegar NH, 8"
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·AMERICAN OPTISURGICAL, INC.·Product code LFL·January 23, 2014
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·AOI, INC.·Product code LFL·January 23, 2014
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·AOI, INC.·Product code LFL·January 23, 2014
BLOOD GLUCOSE MONITORING SYSTEM, MODELS AG-6081 AND AG-6951
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AZUR DETACHABLE 35 PLATINUM COIL SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
TX1 TISSUE REMOVAL SYSTEM - MICROTIP
FDA Adverse Event
Malfunction
·AOI·Product code LFL·January 23, 2014
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 20, 2016
BIA400 IMPLANT 4MM W ABUTMENT 8MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·April 28, 2016
BIA400 IMPLANT 4MM W ABUTMENT 12MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·October 11, 2016
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 26, 2016
BIA400 IMPLANT 4MM W ABUTMENT 8MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·May 25, 2016
BIA400 IMPLANT 4MM WITH ABUTMENT 12MM
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code MAH·June 6, 2016