Recall Z-1433-2025— Zimmer, Inc.

Name: FDA recall Z-1433-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-27

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2025-02-27. It names one FDA 510(k) clearance: K042271. Product: NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10. Reason: The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-02-27
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K042271 — NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACESZimmer, Inc.·cleared 2004-10-13

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 LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Reason for recall

The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

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