Recall Z-0092-2014 ยท DZJ Driver, Wire, And Bone Drill, Manual
Stryker Instruments Div. of Stryker Corporation
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 a
| Date | Oct 28, 2013 (initiated Oct 2, 2013) |
| Status | Terminated |
| 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 |
| 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 |
| Quantity | 67 |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943540 | SURGICAL CUTTING BURS Stryker Corp., Nov 30, 1994 |