Manufacturers

Walter Lorenz Surgical, Inc.

  • Manufacturer Address
    Walter Lorenz Surgical, Inc., 1520 Tradeport Dr, Jacksonville FL 32218-2480
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA
  • 3 Events

3 devices in the database

Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM
  • Model / Serial
    Lot # 968720
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
  • Product Description
    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.
Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM
  • Model / Serial
    Lot # 976580 and Lot # 970060
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
  • Product Description
    Product is 65mm Flexible 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 # 80-3112-01 Lot 976580 Qty 41 10/18/2005. || Sold for use with: || Part # 80-3112-01 Lot # 976580 Qty 28. || Part # SP-1652 Lot # 048720 Qty 3. || Part #-1640 Lot # 056620 Qty 8. || Part # SP-1651 Lot # 056590 Qty 2. || Part # 80-3112-01 Lot 970060 Qty 31 10/20/2005. || Sold for use with: || Part # SP-1651 Lot # 056590 Qty 8. || Part # SP-1653 Lot # 056610 Qty 10. || Part # SP-1285 Lot # 056570 Qty 4. || Part # SP-1652 Lot # 056600 Qty 9. || 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.
Device Recall LORENZ RESORBABLE DISTRACTOR SYSTEM
  • Model / Serial
    Lot # 052190
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
  • Product Description
    Product is 40mm Flexible 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 # 80-3111-01 Lot 052190 QTY 76 Pieces 10/18/2005. || Sold for use with: || Part # 80-3111-01 Lot 052190 Qty 14. || Part # SP-1651 Lot # 069330 Qty 10. || Part # SP-1639 Lot # 046230 Qty 4. || Part # SP-1598-13 Lot # 041960 Qty 10. || Part # SP-1329 Lot # 039700 Qty 10. || Part # SP-1331 Lot # 039720 Qty 12. || Part # SP-1330 Lot # 039710 Qty 11. || Part # SP-1633 Lot # 056630 Qty 5. || 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.