FDA Device recall Z-1741-2013
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performanc…
- FDA Device
- Class II
- terminated
- Published 2013-07-24
On 2013-07-24 the FDA classified a Class II recall of CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performanc… by Stryker Instruments Div, citing the safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect paramet….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1741-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-01 |
| Published | 2013-07-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein 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
The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100
Identifiers
| code_info | Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033…Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1741-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.