Recall Z-1508-2009 ยท HAX Tong, Skull For Traction
Ossur Engineering, Inc
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.
| Date | Jun 19, 2009 (initiated Nov 9, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root 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, |
| Quantity | 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. |
| FDA record | Open on fda.gov |