Recall Z-0383-2012 ยท JEY Plate, Bone
Walter Lorenz Surgical, Inc.
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 Lo
| Date | Jan 11, 2012 (initiated Feb 17, 2006) |
| Status | Terminated |
| 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 | 76 pieces |
| Distribution | Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002083 | LORENZ RESORBABLE DISTRACTOR SYSTEM Walter Lorenz Surgical, Inc., Feb 12, 2001 |