Class 2 Device Recall ReSolve Halo Open Back Halo Ring

• Date Initiated by Firm: November 09, 2008
• Date Posted: June 19, 2009
• Recall Status: Terminated on April 22, 2010
• Recall Number: Z-1508-2009
• Recall Event ID: 50706
• 510(K)Number: K023959 K051918
• Product Classification: Skull Tong for Traction - Product Code HAX
• Product: ReSolve Halo - Open Back Halo Ring, Model Number: 505400D; ; The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
• Code Information: Lot Numbers: 08033120, 08040201, 08050204, 08051414, 08060514, 08070706, 08080710, 08091521, 08093027, and 08102723.
• Recalling Firm/ Manufacturer: Ossur Engineering, Inc; 910 Burstein Dr; Albion MI 49224-4011
• For Additional Information Contact: 517-629-8890
• Manufacturer Reason for Recall: Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
• FDA Determined Cause: Process change control
• Action: Ossur contacted direct consignees and sub-accounts beginning on November 10 , 2008 via a phone call informing them of the recall, and the reason as stated in the public reason for recall. Consignees were asked to check their inventory for any of the identified products and contact them with this information. The firm developed a telephone script for the customer service representatives to use. Ossur then forwarded a notification letter to the affected customers beginning on November 12, 2008 via US Postal Service. In the event that any of these parts have already been applied to a patient, Ossur advised customers to follow their normal follow-up protocols, ensuring that the ceramic pins are properly fixed in the skull. At the time of the phone calls Ossur did not have sterilized open back replacement rings available; however, they offered their ReSolve Closed Back Halo ring as an alternative. The firm estimated that the normal product offering should be available once again in approximately four to six weeks from the date of the phone call.
• Quantity in Commerce: 90 pieces
• Distribution: Worldwide Distribution -- USA including states of CA, GA, FL, MD, MI, MO, & WA and countries of Australia, Cyprus, Germany, Italy, Kuwait, Saudi Arabia, Singapore, South Africa, Spain, United Arab Emirates, and the United Kingdom.
• 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 = HAX and Original Applicant = JEROME MEDICAL; 510(K)s with Product Code = HAX and Original Applicant = THE JEROME GROUP, INC.