Z-0092-2014 Class II Terminated
FDA device recall Z-0092-2014 was initiated by Stryker Instruments Div. Of Stryker Corporation on Oct 2, 2013 and is designated Class II. 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… The recall status is terminated (terminated Apr 15, 2014). Affected quantity: 67.
Recall details
- Product Type
- Devices
- Report Date
- Nov 6, 2013
- Initiation Date
- Oct 2, 2013
- Termination Date
- Apr 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67
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.
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
Distribution pattern
Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
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 ,
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0092-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026