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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker EMS Stair PRO

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 Class 2 Recall
Stryker EMS Stair PRO
see related information
Date Posted February 06, 2012
Recall Status1 Terminated on August 28, 2013
Recall Number Z-0943-2012
Recall Event ID 60422
Product Classification Stretcher, Hand-Carried - Product Code FPP
Product Foot Rest Kit (pN 6252700-003) for Models 6251 and 6252 Stryker (EMS Stair -PRO), OE 2065939, 1739631, 2066066, 6066803 and 20666941 with optional , Stryker Medical, Portage, MI 49002. Intended to provide the patient greater comfort and a sense of security.
Code Information Model 6251 and 6252, The Foot Rest Kit (pN 6252-700-003) Order numbers 2065939, 1739631, 2066066, 2066803, and 2066941.
Recalling Firm/
Manufacturer
Stryker Medical Division of Stryker Corporation
3800 East Centre Ave.
Portage, Michigan 49002
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The Foot Rest Kit may have the wrong pivot spacers making the joint more susceptible to relaxation and prone to fatigue. There is a moderate risk of injury to the patient should the handles become detached during use.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action Stryker Medical spoke with all customers who received these shipments prior to 10/31/2011 requesting information on kits affected and recalled foot rest units installed. December 5, 2011 Urgent Medical Device Recall Letters, with instructions on how to to either install a new Foot Rest Kit ( enclosed ) or dispose of any kits that were not installed were sent to both customers who could have installed recalled foot rest units. Customers needing help or assistance with installation are asked to call Stryker Technical Support a 1-800-327-0770. Customers were to complete and return a postage paid postcard confirming receipt. Customers with questions or concerns are asked to contact Kristin Dudek at 269-389-6927 M-F m 8 a.m. - 5 p.m. (EST).
Quantity in Commerce 3 units
Distribution Nationwide Distribution -- MI & MA.
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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