FDA-Device2013-07-24Class II
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
Stryker Instruments Div. of Stryker Corporation
Hazard
The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100
Sold states
Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
Affected count
11
Manufactured in
4100 E Milham Ave, N/A, Portage, MI, United States
Products
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1741-2013Don't want to check this manually?
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