Z-1508-2009

ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixation device used to...

Name: Z-1508-2009 ReSolve Halo - Open Back Halo Ring, Model Number: 505400D The ReSolve Halo Ring is a fixation device used to...
Creator: Ossur Engineering, Inc
Published: 2008-11-09
License: https://open.fda.gov/license/

Ossur Engineering, Inc / initiated 2008-11-09 / Terminated

FDA source

Ossur Engineering, Inc began a recall of 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 on 2008-11-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1508-2009
Status: Terminated
Initiated: 2008-11-09
Posted: 2009-06-19
Terminated: 2010-04-22
Recalling firm: Ossur Engineering, Inc
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.
Product code: HAX Tong, Skull For Traction
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 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, 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.
Product codes and lots: Lot Numbers: 08033120, 08040201, 08050204, 08051414, 08060514, 08070706, 08080710, 08091521, 08093027, and 08102723.

Product code HAX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)