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U.S. Department of Health and Human Services

Class 2 Device Recall Otto Bock Kimba

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  Class 2 Device Recall Otto Bock Kimba see related information
Date Initiated by Firm October 29, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on November 07, 2005
Recall Number Z-0181-04
Recall Event ID 27588
Product Classification Wheelchair, Mechanical - Product Code IOR
Product Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X
Code Information The affected strollers were sold between August 1, 2002 and September 23, 2003. The affected strollers are those strollers equipped with the trigger-activated tilting mechanism. (The firm''s notification letter has photographs of the trigger-activated tilting mechanism which can be used to identify the devices needing correction.)
Recalling Firm/
Manufacturer		 Bock,Otto,Orthopedic Ind,Inc
3000 Xenium Ln N
Minneapolis MN 55441-2661
For Additional Information Contact Shelley Stockman
763-489-5153
Manufacturer Reason
for Recall		 Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.
FDA Determined
Cause 2		 Other
Action Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers.
Distribution The product was distributed nationwide in the United States and to Canada and Mexico.
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.
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