Class 2 Device Recall

• Date Initiated by Firm: March 31, 2005
• Date Posted: May 03, 2005
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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.