Z-0625-2009

Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked)...

Name: Z-0625-2009 Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked)...
Creator: Stryker Communications Corp
Published: 2008-09-02
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2008-09-02 / Terminated / root cause: manufacturing process

FDA source

Stryker Communications Corp began a recall of Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and... on 2008-09-02. The reason FDA records is "Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0625-2009
Status: Terminated
Initiated: 2008-09-02
Posted: 2009-01-16
Terminated: 2010-01-08
Recalling firm: STRYKER Communications, Inc.
Product: Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit) and 0682-000-416 (Flat Panel Retro Fit Kit); distributed by Stryker Communications, Flower Mound, TX 75028. The 0682-000-414 (FP Shroud version 2 reworked) is a shroud designed to cover the cabling necessary on a Stryker Version 3 Monitor when mounted on the Flat Panel Arm.
Product code: FQO Table, Operating-Room, Ac-Powered
Reason for recall: Paint chips: Shroud used to cover cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms during procedures) was not manufactured/painted to specification, resulting in the possibility that paint chips could fall off and fall into non-sterile and/or sterile fields during surgery. For further information, please contact Stryker Communications Corporation by telephone at 97
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Firm began notifying consignees of recall via letter on 09/02/08. Consignees advised that a representative would shortly visit the facility to replace the shroud with one that complies with specifications. The recall letter is entitled "URGENT: Device Recall."
Quantity in commerce: 116 units.
Distribution: Worldwide distribution; Product distributed nationwide to consignees in the states of CA, FL, IL, IN, MA, MN, NC, NM, OH and TX and to the following countries: Canada, Spain and the United Kingdom,
Product codes and lots: All product shipped between 06/05/06 and 01/31/07.

Product code FQO

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)