Events

Recall of TPS Micro Driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Instruments Div. of Stryker Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0092-2014
  • Event Initiated Date
    2013-10-02
  • Event Date Posted
    2013-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122137
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Driver, wire, and bone drill, manual - Product Code DZJ
  • Reason
    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.
  • Action
    Stryker sent an Urgent Medical Device Correction Notification letter via overnight mail and interntion consignees via E-mail on October 2, 2013. The Urgent Notice identified the recalled product, the reason for the recall, potential adverse risks to health associated with the recall. Customers were instructed to: 1. Immediately review this Recall Notification 2. Locate, and quarantine, the units listed in this notification. Do not use the recalled TPS MicroDriver until it has been repaired. A list, of units shipped to your facility, is included on the attached Business Reply Form. 3. Return the enclosed Business Reply Form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. 6. Upon receipt of the Business Reply Form, Stryker will send you a pre-paid shipper to send your affected device(s) back to Stryker to be repaired. Unit will be repaired and returned to your facility 7. Send back all affected devices using the pre-paid shipper provided to you by Stryker. 8. If you require a loaner, please contact the Stryker Service Department at 888-308-1983. For questions regarding this recall call 269-389-4518.

Device

TPS Micro Driver
  • Model / Serial
    10933, 11433, 11483, 20553, 30163, 31553, 40713, 40833, 41113, 50463, 60133, 60423, 90383, 110093, 110193, 1030133, 1030403, 1040413, 2010013, 2010123, 96090403, 96091343, 97020193, 97030013, 97030543, 97050243, 97060163, 97080033, 98010083, 98020703, 98030103, 98040213, 98060023, 98061033, 98070603, 98090023, 98090473, 98090503, 98101143, 98110323, 99010433, 99030253, 99050033, 99050383, 99060163, 99060423, 99061063, 99061283, 99070453, 99071293, 99080243, 99080483, 99090913, 99101273, 221303733, 326102033, 434909453, 500800103, 504900233, 631112793, 631414853, 700314923, 723606673, 725315933, 735502183, 813304543, and 921700523 .
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
  • Product Description
    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
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA