Z-1740-2013 Class II Terminated
FDA device recall Z-1740-2013 was initiated by Stryker Instruments Div. Of Stryker Corporation on Jul 1, 2013 and is designated Class II. 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… The recall status is terminated (terminated Sep 16, 2013). Affected quantity: 0.
Recall details
- Product Type
- Devices
- Report Date
- Jul 24, 2013
- Initiation Date
- Jul 1, 2013
- Termination Date
- Sep 16, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product description
Stryker TPS Universal Driver REF 5100- 99 Rx , 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.
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
Distribution pattern
Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
Code information
Serial Number 0214200753
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1740-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026