Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related t

FDA device recall Z-1752-2014 · posted 2014-06-11 · Terminated

Recall details

Recalling firm

Stryker Instruments Div. of Stryker Corporation

Reason for recall

There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.

Action taken

Stryker Instruments sent an URGENT MEDICAL DEVICE RECALL notification letter dated May 22, 2014, to the consignees. Recall notification included affected product description and identification, reason for recall, risk to health, and actions to be taken by the customers. Customers will be instructed to review the notification, quarantine unused product and to return a signed Business Reply Form. They will be advised that a Stryker Representative will be sent to their facility to inspect any affected product on hand. Once product is inspected by the Stryker Representative, they can return conforming product back to stock, for normal use. Non-conforming product will be removed from the facility by a Stryker Representative following the inspection process. The Stryker Representative will send the product to the manufacturer for destruction. For questions regarding this recall please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HBE

Quantity affected

281

Distribution

Worldwide Distribution - US (nationwide)

Date initiated

2014-05-22

Date posted

2014-06-11

Date terminated

2015-05-06

Location

Portage, MI