Recall Z-2519-2023— Zimmer, Inc.

Name: FDA recall Z-2519-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-26

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2023-07-26. It names one FDA 510(k) clearance: K200823. Product: M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440). Reason: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-07-26
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K200823 — Zimmer, Inc. Hip Joint Prostheses MR Labeling IZimmer, Inc.·cleared 2020-07-09

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

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

Reason for recall

The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

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