129 results
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63ms
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Sources: EU EUDAMED, US FDA
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
FDA Enforcement
Class II
·Terminated·Linvatec Corp. dba ConMed Linvatec·August 15, 2012
SMARTSCREW ACL
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS LTD.·Product code MAI·January 10, 2006
BANKART TACK
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS LTD,·Product code MAI·October 31, 2005
CONTOUR MENISCUS ARROW
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS, LTD.·Product code MAI·October 11, 2004
CONTOUR MENISCUS ARROW
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS LTD.·Product code MAI·October 11, 2004
SMARTSCREW
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS LTD.·Product code MAI·October 18, 2004
CONTOUR MENISCUS ARROW
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS LTD.·Product code MAI·October 11, 2004
RAVEN SUTURE RETRIEVER
FDA Adverse Event
Other
·LINVATEC BIOMATERIALS, LTD.·Product code LXH·August 25, 2005
PopLok Punch labeled in part: "PKL-35M***3.5mm***QTY 1***PopLok Punch***ConMed Linvatec Biomaterials, Ltd. Hermiankatu 6-8L 33720 Tampere, FINLAND***Rx Only***ConMed Linvatec 11311 Concept Blvd Largo, FL 33773-4908 USA***Made in USA***" Intended Use: Bone Punch.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code LXH·July 6, 2012
"***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" The non absorbable suture anchor is intended to reattach soft tissue to bone in orthopedic surgical procedures.
FDA Recall
Terminated
·Linvatec Corp. dba ConMed Linvatec·Product code MBI·January 26, 2011
SMARTPIN, 2.0 X 30MM
FDA Adverse Event
Other
·CONMED LINVATEC BIOMATERIALS LTD.·Product code MAI·March 3, 2009
CANNULATED SMARTSCREW, 4.5X60MM
FDA Adverse Event
Injury
·CONMED LINVATEC BIOMATERIALS LTD.·Product code HWC·February 3, 2009
MATRYX INTERFERENCE SCREW, 9.0 X 25MM
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS LTD.·Product code HWC·April 14, 2010
VORTEX
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS, LTD·Product code HRX·October 14, 2014
BANKART TACK
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS LTD·Product code MAI·May 25, 2007
DUET SUTURE ANCHOR
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS LTD·Product code MAI·April 24, 2007
MATRYX INTEFERENCE SCREW
FDA Adverse Event
Other
·CONMED LINVATEC BIOMATERIALS LTD·Product code MAI·May 25, 2007
MATRYX INTERFERENCE SCREW
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS LTD·Product code MAI·June 21, 2007
DUET SUTURE ANCHOR
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS LTD·Product code MAI·April 30, 2007
DUET SUTURE ANCHOR
FDA Adverse Event
Malfunction
·CONMED LINVATEC BIOMATERIALS LTD·Product code MAI·June 21, 2007