Stryker TPS Universal Driver Recalled for Unintended Activation Risk
Stryker is recalling TPS Universal Drivers due to incorrect programming that may cause unintended activation, posing a risk of injury to patients or users.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential injury without confirmed cases.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is recalling the Stryker TPS Universal Driver (REF 5100-99 Rx). The recall is due to safety margin values being entered incorrectly into the programming software. This error affects handpieces that have been programmed with these incorrect parameters.
The defect could result in unintended forward or reverse activation of the handpiece. This unintended activation presents a potential for injury to the patient or the user. The source text also notes a potential that the handpiece may not reach 100, though the specific metric is cut off in the provided text.
The affected product is distributed worldwide, including in the United States (AZ, FL, GA, NC, NY, SC, TX, and VA) and in India, the Netherlands, and Japan. The specific serial number identified in the recall is 0214200753. Users should stop using the affected handpieces and contact Stryker for instructions on how to proceed.
The recalled product
- 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, max
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Number 0214200753
Distribution
Part of a larger recall action
This product is one of 3 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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