FDA Device recall Z-1002-2019
Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App
- FDA Device
- Class II
- terminated
- Published 2019-03-20
On 2019-03-20 the FDA classified a Class II recall of Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App 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-1002-2019 |
| 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, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App; JT-200/ J TONG ASSEMBLY SML/MED; JT-210/ J TONG ONLY SML/MED; JT-400/ J TONG COMPONENT TRAY
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-1002-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.