Recall Z-1608-2024— Zimmer, Inc.

Name: FDA recall Z-1608-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-28

Class II · Ongoing

Class II FDA medical device recall by Zimmer, Inc., initiated 2024-03-28. It names one FDA 510(k) clearance: K031061. Product: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.. Reason: Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-03-28
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K031061 — NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTSZimmer, Inc.·cleared 2003-10-09

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

NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.

Reason for recall

Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

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