FDAClass IIMarch 19, 2025

Z1 Femoral Hip System recall

Z1 Femoral Hip System, Product Number 611777612

Why was Z1 Femoral Hip System recalled?

There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277

Product
Z1 Femoral Hip System, Product Number 611777612
Recalling firm
Zimmer, Inc.
Quantity
35 units
Distribution
US Nationwide distribution.
Recall date
March 19, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls