109 results
·
73ms
·
Sources: EU EUDAMED, US FDA
*
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code JEY·July 29, 1998
Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711. Part # SP-1328-01 Lot 968720 Qty 34 10/6/2005. Sold for use with: Part # SP-1598-13 Lot # 041950 Qty 10. Part # SP-1597-13 Lot # 066720 Qty 9. Part # SP-1598-13 Lot 050140 Qty 15. Product Usage: Distraction devices are for use in bone stabilization and elongation (lengthening) when correction of oral, cranial, mandibular and maxiollofacial deficiencies or post traumatic defects require gradual bone distraction. Each implantable distraction device has a titanium alloy drive screw mechanism and LactoSorb resorbable correction plates, which are implanted by fixation with LactoSorb bone screws.
FDA Recall
Terminated
·Walter Lorenz Surgical, Inc.·Product code JEY·February 17, 2006
2.0/1.0 6 HOLE MEDIUM COMPRESSION PLATE
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code JEY·January 24, 2004
ALVEOLAR RIDGE DISTRATOR PLATE
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code MQN·March 22, 2002
*
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code MQN·March 1, 2002
MANDIBULAR DISTRATOR PLATE
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code MQN·March 22, 2002
ALVEOLAR RIDGE DISTRACTOR PLATE
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code MQN·March 22, 2002
PECTUS STABILIZER
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code HRS·May 10, 2000
LORENZ TWIST DRILL 1.5X76MM
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code HTW·March 6, 2003
LORENZ PECTUS SYSTEM
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code HRS·April 7, 2005
SMALL FRAGMENT 4X2 HOLE RECTANGLE PLATE
FDA Adverse Event
Other
·WALTER LORENZ SURGICAL, INC.·Product code HRS·April 22, 2005
LORENZ PECTUS SYSTEM
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code HRS·April 7, 2005
LORENZ PECTUS SUPPORT BAR
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code HRS·May 17, 1999
1.5MM SYSTEM PLATE
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code JEY·April 30, 1999
1.5MM SYSTEM PLATE
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code JEY·May 10, 1999
LORENZ PECTUS SUPPORT BAR
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code IME·June 22, 1999
PECTUS STABILIZER PLATE
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code HRS·April 23, 1999
LORENZ PECTUS SUPPORT BAR
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code HRS·May 7, 1999
1.5MM SYSTEM PLATE
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code JEY·April 30, 1999
1.5MM SYSTEM PLATES
FDA Adverse Event
Injury
·WALTER LORENZ SURGICAL, INC.·Product code JEY·April 30, 1999