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

FDA device recall Z-0092-2014 · posted 2013-10-28 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DZJ

Quantity affected

67

Distribution

Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.

Date initiated

2013-10-02

Date posted

2013-10-28

Date terminated

2014-04-15

Location

Portage, MI

Related 510(k) clearances