CORE Universal Driver REF 5400- 99 Rx Only This drill may also be… — Class II medical device recall Z-1741-2013
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2013-07-24, distributed nationwide. The safety margin values detailed in the Engineering Design were entered incorrectly into the programming soft
| Recall number | Z-1741-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2013-07-01 |
| Classified | 2013-07-16 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2013-09-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | IN, JP, NL |
| Quantity | 11 |
| Reason classes | software |
| Serial numbers | 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093, 0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083, 1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, 1128022593 |
| Model numbers | 5400 |
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 for recall
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.