Recall Z-0997-2019

Reason for recall

Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.

FDA-determined cause: Labeling design

Action taken

On 06/21/2018, Urgent Field Safety Notices were mailed to customers via UPS Next-Day Air requiring a signature of acceptance from the customer. Customers were advised the following: 1. Please pass this notice to those who need to be aware within your organization or to any department areas where the potentially affected devices will be used or transferred. 2. Maintain awareness on this notice for an appropriate period. 3. If you would like to have the product replaced please contact your customer service or sales representative and new product will be provided. Customers can exchange the affected product, if they desire to do so. Customers were asked to distribute the notices to those who need to be aware within their organization or to any department areas where the potentially affected devices were used or transferred. On 01/14/2019, Urgent Medical Device Recall letters were sent via express mail requiring a signature of acceptance from the customer. Customers were advised: Please examine your inventory, quarantine products subject to the recall and contact customer service for a return authorization to return the product. In addition: 1. Please confirm receipt of this recall notice by calling customer service (800-233-6263) or visit https://safetyalert.ossur.com 2. Please pass this notice to those who need to be aware within your organization and to any department areas where the potentially affected devices will be used or transferred (e.g. MR Imaging, Surgical, Emergency, Material Management, Patient) 3. Maintain awareness on this notice for an appropriate period. 4. If you have further distributed this product, please identify your customers and notify them at once of this product alert. We recommend that you include a copy of this product recall. 5. If any of your patients is currently wearing the product, necessary arrangements should be made to ensure the patient is not placed in MR Imaging.