Recall Z-1329-2025— Zimmer, Inc.

Name: FDA recall Z-1329-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-12

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2025-02-12. It names one FDA 510(k) clearance: K233476. Product: Z1 Femoral Hip System, Product Number 611777612. Reason: There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K233476 — Z1 Hip SystemOrchard Medical Development·cleared 2024-02-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.