Class 2 Device Recall Coupler System II

• Date Initiated by Firm: February 27, 2012
• Date Posted: March 13, 2012
• Recall Status: Terminated on September 25, 2012
• Recall Number: Z-1203-2012
• Recall Event ID: 61275
• Product Classification: Accessories, operating-room, table (kit) - Product Code FWZ
• Product: Coupler System II; ; Mizuho Orthopedic Systems, Inc.; Union City, CA 94587; ; The 5873 Coupler II is designed for use specifically with the Mizuho OSI Modular Base and the Spinal System Table Tops (AKA Jackson Spinal Table Top). The Coupler II mounts onto the Spinal Surgery Top by using the Spinal Top Adaptor Brackets. The 5873 Coupler II is used to allow positioning of a patient on the table utilizing either a skull clamp or horseshoe headrest for cranial stabilization or support during surgical procedures. The Coupler II can be accommodate either a radiolucent or aluminum skull clamp manufactured by Integra Life Sciences, referred to as a Mayfield¿ clamp or the radiolucent or aluminum skull clamp referred to as the DORO¿ which is manufactured by pro med instruments Inc.
• Code Information: Model 5873
• Recalling Firm/ Manufacturer: Mizuho Orthopedic Systems Inc; 30031 Ahern Ave; Union City CA 94587
• For Additional Information Contact: Kirke Jayne; 510-476-8128
• Manufacturer Reason for Recall: Mizuho determined that current labeling of The Coupler II system required revisions after investigation of a complaint.
• FDA Determined Cause: Labeling design
• Action: Mizuhosi OSI sent an Urgent Medical Device Recall Communication letter dated February 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Mizuho OSI provided their customers of the affected product an updated Owner's manual. Customers were instructed to ensure they remove their existing Owner's Manual from use and repalce with the current Owner's Manual. If customers were unsure of the device's use, they should refer to the included Owner's Manual and ensure all users are properly trained, able to assess the device's status prior to and after each use. If customers were unsure of the status of their device, or of its use, they should call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. Customers were asked to respond that the recall has been received, read, understood and communicated to those affected by this activity. A response should be sent via e-mail to couplerII@mizuhois.com. For any questions regarding this recall call 1-800-777-4674 or outside of the USA 00+1=510-476-8199. was sent out on February 27, 2012 to all affected sites. This was after the original was sent to CDRH for review on January 31, 2012, but approval of revisions was not received until 2/27/12.
• Quantity in Commerce: 1077 devices
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Belgium, Canada, France, Germany, Hong Kong, Israel, Japan, South Korea, Lebanon, Malaysia, Netherlands, New Zealand, South Arabia, Singapore, Germany, South Africa, Spain, Sweden, UA. E., United Kingdom, and Australia.
• 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.