ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore
FDA device recall Z-0037-2013 · posted 2012-10-10 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
- Action taken
- Medtronic conducted a conference call on August 30, 2012 and sent an "URGENT VOLUNTARY RECALL" notice dated September 3, 2012 to all affected customers. The notice identified the product, problem, and actions to be taken by the customers. A Recall Questionnaire Form was attached to the letter for customers to complete and return. Contact your Medtronic Sales representative or the firm's Global Quality Department at 800-876-3133, ext. 3197 for questions regarding this notice.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 1014 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
- Date initiated
- 2012-08-30
- Date posted
- 2012-10-10
- Date terminated
- 2013-08-15
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (K081038) | Medtronic Sofamor Danek | 2008-08-15 |
| ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE (K063100) | Medtronic Sofamor Danek, Inc. | 2007-02-23 |
| ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM (K021461) | Medtronic Sofamor Danek | 2002-07-22 |