Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE OR
FDA device recall Z-0384-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Walter Lorenz Surgical, Inc.
- Reason for recall
- Lorenz Engineer discovered flex tube could break if bent too much.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 41 pieces and 31 pieces respectively
- Distribution
- Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan.
- Date initiated
- 2006-02-17
- Date posted
- 2012-01-11
- Date terminated
- 2011-12-12
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LORENZ RESORBABLE DISTRACTOR SYSTEM (K002083) | Walter Lorenz Surgical, Inc. | 2001-02-12 |