FDA Medical Device Recalls (openFDA)
Walter Lorenz Surgical, Inc.: 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.
- Recall number
- Z-0384-2012
- Recalling firm
- Walter Lorenz Surgical, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2006-02-17
- Posted
- 2012-01-11
- Terminated
- 2011-12-12
- Reason
- Lorenz Engineer discovered flex tube could break if bent too much.
- Root cause
- Device Design
- Action
- W. Lorenz Surgical notified consignees of recall by an Urgent Advisory Notice letter. Consignees were requested to acknowledge receipt of recall and provide product disposition. Initial letter was sent on March 2, 2006, March 15, 2006, follow-up letters sent on April 4, 2006 and May 15, 2006. For additional information call (904) 741-4400 or fax (904) 741-4500.
- Quantity
- 41 pieces and 31 pieces respectively
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
- Lot, serial or model codes
- Lot # 976580 and Lot # 970060
- 510(k) numbers
- ["K002083"]
- PMA numbers
- not on file
- Product code
- JEY
- Firm FEI
- 1032347
- Firm city
- Jacksonville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28