Z1 Femoral Hip System, Product Number 611777612
FDA Recall #Z-1329-2025 — Class II — February 12, 2025
Product Description
Z1 Femoral Hip System, Product Number 611777612
Reason for Recall
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
35 units
Distribution
US Nationwide distribution.
Code Information
UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated