Recall Z-1740-2013— Stryker Instruments Div. of Stryker Corporation

Name: FDA recall Z-1740-2013
Creator: U.S. Food and Drug Administration
Published: 2013-07-01

Class II · Terminated

Class II FDA medical device recall by Stryker Instruments Div. of Stryker Corporation, initiated 2013-07-01, terminated 2013-09-16. It names one FDA 510(k) clearance: K040300. 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.. 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.

Recalling firm: Stryker Instruments Div. of Stryker Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-07-01
Terminated: 2013-09-16
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K040300 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)Stryker Instruments·cleared 2004-03-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.