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

Recall Z-0657-2019 — Reliance LITe Nerve Hook Bayoneted, 90, Blunt Tip, REF # 48066103 The blunt probe can be used as a conventional means of achieving nerve retraction. The bend at the proximal tip of the ring the discectomy, as well as during the insertion of an IBD during a conventional TLIF procedure.

U.S. FDA — Device Enforcement · United States · 2018-11-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0657-2019
Date of alert
2018-11-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Howmedica Osteonics Corp.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
48066103
Reported risk: Instead of having a spherical diameter, the probe was observed to have 2 radii and a flat surface. Additionally, upon further investigation, it was observed that some parts exhibited an edge on the intersection between the radius and the diameter of the probe.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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