FDA-Device2025-12-31Class IIPROCESSING DEFECT

Zimmer Affixus Antegrade Femoral Nailing System recalled for undersized shaft risking fracture

OTHERNationwide distribution

Contact your surgeon about Zimmer Affixus nail

Zimmer Affixus Antegrade Femoral Nails (9 mm, 400 mm length, left side) may have a smaller-than-intended diameter along the shaft. This could cause the implant to weaken and break over time, leading to pain, improper bone healing, or the need for additional surgery.

If you received this implant, contact your surgeon or orthopedic doctor right away with the lot number from your medical records
Do not delay—discuss your implant status and any symptoms you're experiencing
Your doctor will advise whether monitoring, imaging, or replacement is needed

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: 815609400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Left, Trochanteric Nail Component: N/A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0979-2026

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