ReSolve Halo - Open Back Halo Ring, Model Number: 505400D recallZ-1508-2009 · Ossur Engineering, Inc · initiated Nov 9, 2008

Why it was recalled

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 category: Process change control

What the company is doing

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.

Recall details

Recall number

Z-1508-2009

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Nov 9, 2008

Posted by the FDA

Jun 19, 2009

Recalling firm

Ossur Engineering, Inc

Quantity

90 pieces

Product code

HAX

FDA submissions

K023959, K051918

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 description

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.

Other devices under the same FDA submission

1 device cleared under K023959, K051918 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Halo Systems 515400D

  Ossur Americas, Inc. · TONG, SKULL FOR TRACTION
  1 death2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 50706).

• Z-1507-2009 · Terminated
  ReSolve Halo - Open Back Halo Ring, Model Number: 505300D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.
• Z-1509-2009 · Terminated
  ReSolve Halo - Open Back Halo Ring, Model Number: 510400D The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury.