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

Recall Z-0810-2018 — AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement between the two components to permit a controlled positioning of the implant in the anterior portion

U.S. FDA — Device Enforcement · United States · 2017-09-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0810-2018
Date of alert: 2017-09-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Howmedica Osteonics Corp.
Product category: device
Product type: Devices

Reported risk: When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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