FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nailing System recalled for fracture risk

OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus nail

Zimmer, Inc. is recalling specific lots of Affixus Antegrade Femoral Nails (9 mm, 420 mm length, left side) used in thighbone fracture surgery. Some implants may have a manufacturing defect that weakens the nail shaft, increasing the risk of the implant breaking inside the leg.

If you had thighbone fracture surgery with an Affixus nail, contact your surgeon or hospital immediately with your surgery date and location.
Ask your surgeon to check your surgical records to see if you received one of the recalled nail lots (66717606 or 66892905).
Do not delay—a broken implant may require additional surgery.
Watch for new or worsening leg pain, instability, or difficulty walking, and report these symptoms to your doctor right away.

Hazard

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Sold states

US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.

Affected count

Manufactured in

1800 W Center St, N/A, Warsaw, IN, United States

Products

Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0980-2026

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief