RemB Electric Universal Driver REF 6400-099-000 For use with the CORE… — Class II medical device recall Z-1742-2013
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2013-07-24, distributed nationwide. The safety margin values detailed in the Engineering Design were entered incorrectly into the programming soft
| Recall number | Z-1742-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2013-07-01 |
| Classified | 2013-07-16 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN, JP, NL |
| Quantity | 9 |
| Reason classes | software |
| Model numbers | 6400-099-000 |
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 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).
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.