The Recall Desk
HighFDA (Devices)·Z-1741-2013·Announced 2013-07-24

Stryker CORE Universal Driver Recalled for Unintended Activation Risk

Stryker is recalling 11 CORE Universal Drivers because incorrect programming parameters may cause unintended activation, posing a potential injury risk to patients and users.

What this means for you

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 involves a risk of injury to patients or users from unintended activation, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 11 units of the CORE Universal Driver (REF 5400-99). The recall is due to a programming error where safety margin values from the Engineering Design were entered incorrectly into the software. This error may cause the handpiece to activate unintentionally in either the forward or reverse direction, or fail to reach 100% speed.

The affected devices are intended for use in cutting, drilling, reaming, decorticating, and smoothing bone and other bone-related tissues in ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The recall covers units distributed worldwide, including the United States (AZ, FL, GA, NC, NY, SC, TX, and VA) and India, the Netherlands, and Japan. Specific serial numbers are listed in the agency's recall record.

Healthcare providers should stop using the affected devices and contact Stryker for instructions on return or replacement. The agency classifies this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues fo
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
11

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 (19)

  • Serial Number 0326801633
  • 0330802913
  • 0406200763
  • 0410401383
  • 0410600013
  • 0534203093
  • 0627600783
  • 0730101013
  • 0730101033
  • 0805000553
  • 0809829593
  • 0935603083
  • 1011903103
  • 1011903493
  • 1013814003
  • 1025400463
  • 1025400643
  • 1126901343
  • and 1128022593

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · unintended activation

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