Z-1003-2019Class II

Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo...

Name: Z-1003-2019 Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo...
Creator: Ossur Americas
Published: 2018-06-21
License: https://open.fda.gov/license/

Ossur Americas / initiated 2018-06-21 / Terminated / root cause: labeling and UDI

FDA source

Ossur Americas began a recall of Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall... on 2018-06-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1003-2019
Classification: Class II
Status: Terminated
Initiated: 2018-06-21
Posted: 2019-03-11
Terminated: 2020-09-04
Recalling firm: Ossur Americas
Product: Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel; 545700L/ ReSolve Halo Vest-shrt lmbwool; 545800K/ ReSolve Halo Vest-tall kodel; 545800L/ ReSolve Halo Vest-tall lmbwool
Product code: KQZ Component, Traction, Non-Invasive
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 381
Distribution: U.S.: HI, AL, CA, WA, AZ, TX, NM, NE, MI, IL, MN, MS, IN, OH, KY, TN, AK, AL, UT, SC, NC, GA, PA, FL, NY, DE, RI, VA, MA; Foreign: Australia, Germany, New Zealand, Belgium
Product codes and lots: All lots of the products manufactured from 06/30/2009 - 12/13/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1003-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0997-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-0998-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-0999-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-1000-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-1001-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-1002-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-1003-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11
Z-1004-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-20	2019-03-11

Product code KQZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)