Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (S

FDA device recall Z-0625-2009 · posted 2009-01-16 · Terminated

Recall details

Recalling firm

Stryker Communications Corp

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

Action taken

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."

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FQO

Quantity affected

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,

Date initiated

2008-09-02

Date posted

2009-01-16

Date terminated

2010-01-08

Location

Flower Mound, TX