The Recall Desk
HighFDA (Devices)·Z-0092-2014·Announced 2013-11-06

Stryker TPS Micro Driver Recalled for Silicone Potting Defect

Stryker is recalling 67 TPS Micro Drivers because silicone potting failed to cure properly, which could cause material leakage or electrical malfunction.

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 involves a medical device with a defect that could cause electrical malfunction or material leakage, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 67 units of the REF 5100-088 TPS Micro Driver. This device is a medical instrument used in the Stryker Total Performance System for cutting, drilling, and other bone-related procedures in ENT, dental, orthopedic, and other surgical applications.

The recall was initiated because the silicone potting material, which is used to insulate, stabilize, and provide a moisture barrier to the device's main Printed Circuit Board Assembly (PCBA), failed to properly cure after the prescribed process. Inadequate curing could potentially allow the material to leak to the outside of the handpiece or cause an electrical malfunction.

The affected units were distributed worldwide, including in the United States, Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and the United Kingdom. Users should stop using the affected devices and contact Stryker for further instructions.

The recalled product

Product
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting,
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Instruments
Hazard
Affected units
67

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)

  • 10933
  • 11433
  • 11483
  • 20553
  • 30163
  • 31553
  • 40713
  • 40833
  • 41113
  • 50463
  • 60133
  • 60423
  • 90383
  • 110093
  • 110193
  • 1030133
  • 1030403
  • 1040413
  • 2010013
  • 2010123

Distribution

Distributed nationwide across the United States.

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