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

Recall Z-1904-2016 — Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

U.S. FDA — Device Enforcement · United States · 2016-04-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1904-2016
Date of alert
2016-04-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Reported risk: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
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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