FDAFDA · Food and drugs·Recall number Z-1742-2013
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).
Published July 24, 2013 · Recall initiated: July 1, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
- Lot
- 0910505713, 1029801073, 1225400823, 1314201603, 1314300713, 1314300723, 1314300733, 1314300743, 1314300753, 1314300763, 1314300773, 1314300783, 1314300793, 1314300803, 1314300813, 1314300823, 1314300833, 1314300843, 1314300853, 1314300863, 1314300873, 1314300883, 1314300893, 1314300903, 1314804033, 1314900053, 1314906453, 1314908193
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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