Recall Z-0625-2009 ยท FQO Table, Operating-Room, Ac-Powered
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 o
| Date | Jan 16, 2009 (initiated Sep 2, 2008) |
| Status | Terminated |
| 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 |
| 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.