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

Recall Z-0242-2013 — Dynesys¿ Top-Loading System Cannulated Pedicle + Set Screw

U.S. FDA — Device Enforcement · United States · 2012-09-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0242-2013
Date of alert
2012-09-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer, Inc.
Product category
device
Product type
Devices
Reported risk: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
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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