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U.S. Department of Health and Human Services

Class 2 Device Recall Eye Surgery Stryker Medical Stretchers Model 1089

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  Class 2 Device Recall Eye Surgery Stryker Medical Stretchers Model 1089 see related information
Date Initiated by Firm July 19, 2011
Date Posted July 22, 2011
Recall Status1 Terminated 3 on August 29, 2013
Recall Number Z-2864-2011
Recall Event ID 59201
Product Classification Stretcher, Wheeled - Product Code FPO
Product Eye Surgery Stryker Medical Stretchers Model 1089

Intended to transport patients in a horizontal position.
Code Information Model: 1089 Lots: 1102034587, 1102034588, 1102034589, 1102034590, and 1102034591.
Recalling Firm/
Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage MI 49002
For Additional Information Contact Matt Jordan
Manufacturer Reason
for Recall
The firm has determined that the brake rod assemblies of various stretchers that were built with a 5th wheel were manufactured with roll pins that did not meet the materials specifications. Some roll pins may have fractured during the assembly process and could fall out of the brake rod assemblies, rendering the brake or steer systems inoperable from certain pedals or causing a reduction in overa
FDA Determined
Cause 2
Nonconforming Material/Component
Action Stryker Medical sent an "Urgent Medical Device Correction" dated July 19 ,2011 to all affected customers. The letter included; the name and model numbers of the stretchers, the reason for the correction and dates of manufacture. It contained the instructions to check the braking system and if found to be inoperable, to remove it from service, and if operable to check prior to each use. Also, information regarding contacting the recipients of any loaned or sold stretchers to relay the information in the letter and Medwatch reporting information. A self addressed postcard to confirm receipt of the letter was also included. For additional information call (269) 389-6604.
Quantity in Commerce 5
Distribution Worldwide Distribution: Nationwide (USA) including the states of NY, MI, LA and CA ,and the countries of Canada, China, Spain, Japan, Korea, United Kingdom, South Africa.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.