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

Recall Z-1616-2016 — Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

U.S. FDA — Device Enforcement · United States · 2013-07-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1616-2016
Date of alert
2013-07-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Atlas Spine, Inc.
Product category
device
Product type
Devices
Reported risk: The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.
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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