||October 29, 2012
||Terminated on January 28, 2013
|Recall Event ID
Orthopedic manual surgical instrument -
||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
Distributed in the USA by Stryker Spine
2 Pearl Ct., Allendale NJ 07401-1677 USA
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.
Catalog number 48770610, 48770612, 48770616
2 Pearl Ct
|For Additional Information Contact
||Ms. Michelle Barry
|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.
||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
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.