FDA Recall Terminated

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.

Recall: Z-0625-2009 · Initiated September 2, 2008

Recall

Recall Number: Z-0625-2009
Event Number: 49568
Firm: Stryker Communications Corp
FEI Number: 3002975342
Product Code: FQO
Status: Terminated
Root Cause: Nonconforming Material/Component
Initiated: September 2, 2008
Posted: January 16, 2009
Terminated: January 8, 2010
Address: 1410 Lakeside Pkwy, Ste 100, Flower Mound, TX, 75028-4026

Description

Reason

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

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."

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,

Quantity

116 units.