RemB Electric Universal Driver recall: Software Issue
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…
Why was RemB Electric Universal Driver 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- 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…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 9
- Distribution
- Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
- Recall date
- July 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)