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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 2.0mm Round Fluted Bur

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  Class 2 Device Recall Stryker 2.0mm Round Fluted Bur see related information
Date Initiated by Firm May 22, 2014
Date Posted June 11, 2014
Recall Status1 Terminated 3 on May 06, 2015
Recall Number Z-1751-2014
Recall Event ID 68331
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
Product Stryker 2.0mm Round Fluted Bur
Sterile


Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Code Information Part Number 5820-10-20, Lot Numbers 13347017,14010017
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
269-323-7700
Manufacturer Reason
for Recall		 There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Stryker Instruments sent an URGENT MEDICAL DEVICE RECALL notification letter dated May 22, 2014, to the consignees. Recall notification included affected product description and identification, reason for recall, risk to health, and actions to be taken by the customers. Customers will be instructed to review the notification, quarantine unused product and to return a signed Business Reply Form. They will be advised that a Stryker Representative will be sent to their facility to inspect any affected product on hand. Once product is inspected by the Stryker Representative, they can return conforming product back to stock, for normal use. Non-conforming product will be removed from the facility by a Stryker Representative following the inspection process. The Stryker Representative will send the product to the manufacturer for destruction. For questions regarding this recall please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com
Quantity in Commerce 252
Distribution Worldwide Distribution - US (nationwide)
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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