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U.S. Department of Health and Human Services

Class 2 Device Recall TPS Micro Driver

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  Class 2 Device Recall TPS Micro Driver see related information
Date Initiated by Firm October 02, 2013
Date Posted October 28, 2013
Recall Status1 Terminated 3 on April 15, 2014
Recall Number Z-0092-2014
Recall Event ID 66352
510(K)Number K943540  
Product Classification Driver, wire, and bone drill, manual - Product Code DZJ
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.
Code Information 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 .
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kara Spath
269-389-4518
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 67
Distribution Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZJ and Original Applicant = STRYKER CORP.
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