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Stryker Instruments Div. of Stryker Corporation recalls REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts th
Recalled November 6, 2013 · FDA recall Z-0092-2014 · Stryker Instruments Div. of Stryker
Hazard
It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma · FDA Class II
Units
67
Sold at
Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
Description
It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma
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, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.
Manufacturer(s)
Stryker Instruments Div. of Stryker Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →