Z-1741-2013Class II

CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System...

Name: Z-1741-2013 CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2013-07-01
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-07-01 / Terminated / root cause: software

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of 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... on 2013-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1741-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-01
Posted: 2013-07-16
Terminated: 2013-09-16
Recalling firm: Stryker Corp.
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.
Product code: ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
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
Root cause tag: software
FDA root cause: Process change control
Action: The firm, Stryker Instruments, sent emails beginning May 30, 2013 "URGENT MEDICAL DEVICE CORRECTION" letter dated July 1, 2013 to its customers. The letter identified the device, the reason for the recall, possible adverse events and actions to be taken. The customers were instructed to immediately review this letter, locate the units listed, complete and return the business reply form via FAX to 866-521-2762; or email [email protected]; if you have further distributed this product, please forward this letter and the attached Business Reply Form to all affected locations. After receiving this form, Stryker will send you a pre-paid shipper to send your affected device(s)back to Stryker to be reprogrammed with the correct specifications. Send back all affected devices using the pre-paid shipper provided to you by Stryker. If you require a loaner, please contact the Stryker Service Department to arrange for a loaner at 888-308-1983. For questions regarding this recall please Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-4518 / 269-389-3808 [email protected] / [email protected].
Quantity in commerce: 11
Distribution: Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.
Product codes and lots: Serial Number 0326801633, 0330802913, 0406200763, 0410401383, 0410600013, 0534203093,0627600783, 0730101013, 0730101033, 0805000553, 0809829593, 0935603083,1011903103, 1011903493, 1013814003, 1025400463, 1025400643, 1126901343, and 1128022593

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1741-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1740-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16
Z-1741-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16
Z-1742-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-16

Product code ERL

K040300Class IIStryker Consolidated Operating Room Equipment (Core)Stryker Instruments / cleared 2004-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)