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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm March 31, 2005
Date Posted May 03, 2005
Recall Status1 Terminated 3 on May 09, 2005
Recall Number Z-0793-05
Recall Event ID 31702
510(K)Number K950889  
Product Classification Table, Obstetrical, Ac-Powered (And Accessories) - Product Code HDD
Product Stryker brand Birthing Bed; Model 4701.
Code Information All units manufactured 10/18 through 11/05/04.
Recalling Firm/
Stryker Medical
6300 Sprinkle Rd
Kalamazoo MI 49001
For Additional Information Contact Renata Sila
800-669-4968 Ext. 6689
Manufacturer Reason
for Recall
Trendelenburg and reverse trendelenburg features may not function.
FDA Determined
Cause 2
Action Consignees were notified via letter dated 3/31/05 and Stryker personnel began visiting the facilities to make corrections.
Quantity in Commerce 31
Distribution California, Georgia, Indiana, Iowa, Michigan, Ohio and Pennsylvania.
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.
510(K) Database 510(K)s with Product Code = HDD and Original Applicant = STRYKER CORP.