Recall Z-0163-2013
Stryker Spine · initiated July 5, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: E207315 Catalog number 48770610, 48770612, 48770616 All lots
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0163-2013
- Initiated
- July 5, 2012
- Posted by FDA
- October 29, 2012
- Terminated
- January 28, 2013
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 6154 units
- Distribution
- Nationwide distribution.
- Recalling firm
- Stryker Spine, Allendale, NJ