Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1002-2019 — 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

U.S. FDA — Device Enforcement · United States · 2018-06-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1002-2019
Date of alert
2018-06-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ossur Americas
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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