CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryk

FDA device recall Z-1741-2013 · posted 2013-07-16 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

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

Action taken

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 Kara.spath@stryker.com; 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 kara.spath@stryker.com / jennifer.mars@stryker.com.

Root cause

Process change control

Status

Terminated

Product code

ERL

Quantity affected

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.

Date initiated

2013-07-01

Date posted

2013-07-16

Date terminated

2013-09-16

Location

Portage, MI

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