Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
RemB Electric Universal Driver REF 6400-099-000 For use with the Recalled by Stryker Instruments Div. of Stryker Corporation Due to The safety margin values detailed in the Engineering...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.
Affected Products
RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).
Quantity: 9
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report