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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker 3.0mm x 3.8mm Neuro Drill

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 Class 2 Recall
Stryker 3.0mm x 3.8mm Neuro Drill
see related information
Date Posted June 11, 2014
Recall Status1 Open
Recall Number Z-1777-2014
Recall Event ID 68331
Product Classification Drills, Burrs, Trephines & Accessories (Simple, Powered) - Product Code HBE
Product Stryker 3.0mm x 3.8mm Neuro Drill 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 5820-107-430, Lot Number 13350017
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage, Michigan 49002-9704
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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 497
Distribution Worldwide Distribution - US (nationwide)
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.
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