109 results · 73ms · Sources: EU EUDAMED, US FDA

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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

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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