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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Table Headrest

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 Class 2 Recall
Surgical Table Headrest
see related information
Date Posted May 26, 2009
Recall Status1 Terminated on April 26, 2010
Recall Number Z-1418-2009
Recall Event ID 51994
Product Classification Table, Operating-Room, Ac-Powered - Product Code FQO
Product Surgical Table Headrest, Catalog/Part #0788-300-012, component of VERTIER Surgical Table. Distributed as part of the VERTIER Surgical Tables or individually by Stryker Communications, Flower Mound, TX 75028. The Vertier surgical table is intended for use in general surgery or diagnostic examinations to position a patient. The Vertier Surgical Table is an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. The headrest is included with each table.
Code Information All surgical tables with headrest, Catalog/Part #0788-300-012. No Lot numbers.
Recalling Firm/
Manufacturer
Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound, Texas 75028-4026
Manufacturer Reason
for Recall
Potential for health care provider/hospital staff member to sustain injury to fingers or hands when removing/handling the headrest component of the VERTIER Surgical Table.
FDA Determined
Cause 2
DESIGN: Device Design
Action An "URGENT: Device Recall" letter dated May 11, 2009 was issued to consignees. Consignees were informed that Stryker service representatives will visit each location to affix a caution label identifying the pinch point on each headrest. Additionally, consignees will be provided with an updated surgical table user manual. Direct questions to Stryker Communications Corporation by calling 972-410-7100.
Quantity in Commerce 230 headrests.
Distribution Nationwide Distribution and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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