Recall Z-2092-2023— Zimmer, Inc.

Name: FDA recall Z-2092-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2023-05-19. It names one FDA 510(k) clearance: K173057. Product: NexGen Precoat Stemmed Tibial Plate Size 5. Reason: Device outer packaging was incorrectly labeled..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-05-19
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K173057 — Zimmer Knee Joint Replacement Prostheses MR LabelingZimmer, Inc.·cleared 2018-03-29

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

NexGen Precoat Stemmed Tibial Plate Size 5

Reason for recall

Device outer packaging was incorrectly labeled.

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