Stryker RemB Electric Universal Driver Recalled for Unintended Activation
Stryker is recalling nine RemB Electric Universal Drivers because incorrect programming parameters may cause unintended activation, posing a risk of injury to patients or users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II, and the source text identifies a potential for injury to patients or users due to unintended activation, but does not report any actual injuries or hospitalizations.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling nine units of the RemB Electric Universal Driver (REF 6400-099-000). This medical device is intended for use with the Consolidated Operating Room Equipment (CORE) System and the Total Performance System (TPS) for surgical procedures involving driving wire or pins into bone and hard tissue.
The recall was initiated because safety margin values from the Engineering Design were entered incorrectly into the programming software. Handpieces programmed with these incorrect parameters could result in unintended forward or reverse activation. This malfunction presents a potential for injury to the patient or user.
The affected units were distributed worldwide, including nationwide in the United States (specifically in AZ, FL, GA, NC, NY, SC, TX, and VA) and in India, the Netherlands, and Japan. Healthcare facilities and users should stop using the affected devices and contact Stryker for further instructions.
The recalled product
- 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…
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 9
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 (20)
- 0910505713
- 1029801073
- 1225400823
- 1314201603
- 1314300713
- 1314300723
- 1314300733
- 1314300743
- 1314300753
- 1314300763
- 1314300773
- 1314300783
- 1314300793
- 1314300803
- 1314300813
- 1314300823
- 1314300833
- 1314300843
- 1314300853
- 1314300863
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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