Stryker Communications Corp 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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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."