Z-2271-2013Class II

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

Name: Z-2271-2013 Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients...
Creator: Stryker Endoscopy
Published: 2013-08-30
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2013-08-30 / Terminated / root cause: design

FDA source

Stryker Endoscopy began a recall of Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by... on 2013-08-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2271-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-09-24
Terminated: 2014-04-30
Recalling firm: Stryker Corp.
Product: Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
Product code: BZN Cart, Emergency, Cardiopulmonary (Excluding Equipment)
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected] 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. .
Quantity in commerce: 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, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland.
Product codes and lots: Model number 0240-095-200, all serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2271-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2271-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-24

Product code BZN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)