—#127437

Product

Stryker 4.0mm x 5.1mm Neuro Drill Soft Touch 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.

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
Affected lot / code info: Part Number 5820-107-40, Lot Number 13339017

Why it was recalled

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide)

Timeline

Recall initiated: 2014-05-22
Posted by FDA: 2014-06-11
Terminated: 2015-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127437. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.