Company: Stryker Instruments Div. of Stryker Corporation
Date of Enforcement Report: 7/24/2013
Class ll:
PRODUCT
Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in 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.
Recall Number Z-1740-2013
REASON
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% speed at full trigger depression in both forward or reverse, the handpiece may exceed full speed in reverse or may have excessive dead trigger travel before motor rotation in reverse, resulting in user annoyance.
RECALLING FIRM/MANUFACTURER
Stryker Instruments Div. of Stryker Corporation, Portage, MI on 7/1/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
DISTRIBUTION
Nationwide and Internationally
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