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

Recall Z-0797-2016 — Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

U.S. FDA — Device Enforcement · United States · 2016-01-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0797-2016
Date of alert
2016-01-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Orthofix, Inc
Product category
device
Product type
Devices
Reported risk: There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
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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