| | Class 2 Recall
Stryker Spine |  |
| Date Posted |
October 29, 2012 |
| Recall Number |
Z-0163-2013 |
| Product |
Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm,
Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France
+33 (0) 5.57.97.06.30
http://www.stryker.com
Distributed in the USA by Stryker Spine
2 Pearl Ct., Allendale NJ 07401-1677 USA
+1-201-750-8000
Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. |
| Code Information |
E207315
Catalog number 48770610, 48770612, 48770616
All lots
|
Recalling Firm/
Manufacturer |
Stryker Spine
2 Pearl Ct
Allendale, New Jersey 07401-1611 |
| For Additional Information Contact |
Ms. Michelle Barry
201-760-8287
|
Reason for
Recall |
Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
|
| Action |
Stryker Spine sent an Urgent Medical Device Field Correction Notification letter beginning July 5, 2012, to all affected customers. Teh letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the drill bit length in each respective drill guide prior to surgery to ensure the correct length protrudes through the guide. Customers with questions should call 201-760-8298. Customers were asked to report any adverse events or product quality problems to 1-888-457-7463. |
| Quantity in Commerce |
6154 units |
| Distribution |
Nationwide distribution. |
| |
|
|
|
|
