Z-0092-2014Class II

REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA)...

Name: Z-0092-2014 REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA)...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-10-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-10-02 / Terminated / root cause: manufacturing process

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2013-10-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0092-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-02
Posted: 2013-10-28
Terminated: 2014-04-15
Recalling firm: Stryker Corp.
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.
Product code: DZJ Driver, Wire, And Bone Drill, Manual
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
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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 .

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0092-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0092-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-28

Product code DZJ

K943540Class IISurgical Cutting BursStryker Corp. / cleared 1994-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)