Z-1608-2024Class II

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

Name: Z-1608-2024 NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur...
Creator: Zimmer, Inc.
Published: 2024-03-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2024-03-28 / Open, Classified

FDA source

Zimmer, Inc. began a recall of NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System on 2024-03-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1608-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-28
Posted: 2024-04-22
Recalling firm: Zimmer GmbH
Product: NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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.
FDA root cause: Process change control
Action: Consignees were sent an URGENT MEDICAL DEVICE RECALL notification dated 3/28/24. Distributors are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory, return all affected product from the respective distributorship and affected hospitals to Zimmer by submitting an Inventory Return Certification Form to [email protected] (international returns are to be coordinated by emailing [email protected]), and retain a copy of the Inventory Return Certification and product returns forms. Risk Managers are to review the provided notification, notify the appropriate team members of the contents of the notification, locate and quarantine affected product in your inventory with the assistance of a Zimmer Biomet sales representative, the Zimmer Biomet sales representative will remove affected devices from consignee facilities, return the provided Certificate of Acknowledgement to [email protected], and retain a copy of the acknowledgement form for your records. Surgeons are to review the provided notification, complete the provided Certificate of Acknowledgement to [email protected], retain a copy of the acknowledgement form for your records; there is no specific patient monitoring instructions related to this recall. Consignees with any questions are to contact Customer Service at 574-371-3071 from Monday through Friday between the hours of 8:00 am and 5:00 pm EST.
Quantity in commerce: 5,546 units
Distribution: Worldwide distribution - US Nationwide including the states of AK, AL, CA, FL, GA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and the countries of Australia, Canada, Japan, Netherlands.
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1608-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1608-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-22

Product code JWH

K031061Class IINexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. / cleared 2003-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)