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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Spine

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  Class 2 Device Recall Stryker Spine see related information
Date Initiated by Firm July 05, 2012
Date Posted October 29, 2012
Recall Status1 Terminated 3 on January 28, 2013
Recall Number Z-0163-2013
Recall Event ID 63272
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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 NJ 07401-1611
For Additional Information Contact Ms. Michelle Barry
201-760-8287
Manufacturer 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 2		 Device Design
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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