FDA Device recall Z-1003-2019
Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel
- FDA Device
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-shrt kodel by Ossur Americas, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1003-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-21 |
| Published | 2019-03-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ossur Americas |
| Distribution | AK, AL, AZ, CA, DE, FL, GA, HI, IL, IN, KY, MA, MI, MN, MS, NC, NE, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WA |
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
Reason
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.
Identifiers
| code_info | All lots of the products manufactured from 06/30/2009 - 12/13/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1003-2019%22
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