Zimmer NexGen CR-Flex Femoral Component Recall: Gap in Metal Bonding
Zimmer recalls NexGen CR-Flex Femoral Components (Size E and E-) due to a gap in metal bonding that could cause failure. Affected items have specific UDI codes listed in the recall.
Lower-risk 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.
Contact the company
What happened, in plain English
Zimmer is recalling NexGen CR-Flex Femoral Components (Size E and E-) because a manufacturing defect causes gaps in the metal bonding. This could lead to component failure during surgery. Affected items have specific UDI codes listed in the recall. Read more at govinfonow.com/recall/55686-zimmer-nexgen-cr-flex-femoral-component-recall-gap-in-metal.
Source Summary by GovInfoNow · govinfonow.com/recall/55686-zimmer-nexgen-cr-flex-femoral-component-recall-gap-in-metal · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1608-2024
Cite this page
“Zimmer NexGen CR-Flex Femoral Component Recall: Gap in Metal Bonding.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55686-zimmer-nexgen-cr-flex-femoral-component-recall-gap-in-metal. Based on FDA recall #Z-1608-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1608-2024%22&limit=1).
Why it’s dangerous
The components have a gap in the bonding between the fiber metal pad and substrate due to an out-of-specification violation. This gap could cause the pad to not fully bond, potentially leading to component failure during surgery.
Who’s affected
Orthopedic surgeons and medical facilities that use Zimmer's NexGen CR-Flex Porous Femur System components. The risk is low as this is a manufacturing defect that may not cause immediate failure.
How to tell if you have this one
Check if your NexGen CR-Flex Femoral Component (Size E or E-) has the specific UDI codes listed in the recall, which include a range of lot numbers starting with 64115713 and ending with 66378834.
- Brand
Zimmer- Product
NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen CR-Flex Porous Femur System- Category
Medical device
What to do — step by step
Check UDI Codes
Look for the UDI codes listed in the recall (e.g., 64115713, 64175075, etc.) on the product.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 30 states.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, California, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 34 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1608-2024 (March 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1608-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.