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

Recall Z-2067-2014 — Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.

U.S. FDA — Device Enforcement · United States · 2014-07-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2067-2014
Date of alert
2014-07-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Innovasis, Inc
Product category
device
Product type
Devices
Reported risk: Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number.
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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