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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CORE

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  Class 2 Device Recall Stryker CORE see related information
Date Initiated by Firm June 24, 2016
Date Posted July 19, 2016
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-2238-2016
Recall Event ID 74639
510(K)Number K143399  
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product 2.3MM Tapered Router,
Product Number 5407-FA2-023
A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat
(ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and
Sternotomy. They are intended to be used with the Stryker CORE" system.
Code Information Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
Recalling Firm/
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kelly Jo Davis
Manufacturer Reason
for Recall
A variation in flute depth on the routers was observed. The variation in flute depth may cause the routers to be more susceptible to breakages. Risk to Health: Injury to critical soft tissue requiring surgical intervention may occur.
FDA Determined
Cause 2
Process design
Action Stryker sent an Urgent Medical Device Recall Notification letter dated June 24, 2016, to the affected customers via courier, and to Sales Representatives and international affiliates via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at 269-389-2921.
Quantity in Commerce 3,163
Distribution Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
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.
510(K) Database 510(K)s with Product Code = HBE and Original Applicant = STRYKER CORP.