Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model numb

FDA device recall Z-2271-2013 · posted 2013-09-24 · Terminated

Recall details

Recalling firm

Stryker Endoscopy

Reason for recall

When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.

Action taken

Stryker Endiscopy sent an Urgent Device Correction letter dated August 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform individuals within their organization who needed to be aware of this Medical Device Field Correction, contact Stericycle at 1-877-546-0482 or email stryker4645@stericycle.com to schedule a time for Stericycle to perform the correction, or perform the correction themselves by requesting the materials and following the correction instructions included. Customers were also instructed to report all adverse events or product quality problems to Stryker Endoscopy at 1-800-624-4422, press 3 for Customer Service. --UPDATE-- On September 17, 2013, the recall was expanded to include additional customers who may have received the screw and washer included with the design change update. Notification was sent to these consignees on September 17, 2013. .

Root cause

Device Design

Status

Terminated

Product code

BZN

Quantity affected

14271 units

Distribution

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, S

Date initiated

2013-08-30

Date posted

2013-09-24

Date terminated

2014-04-30

Location

San Jose, CA