Affixus Antegrade Femoral Nails Recalled for Potential Fracture Risk

Agency Publication Date: December 22, 2025

Summary

Zimmer, Inc. has recalled approximately 347 Affixus Antegrade Femoral Nails because some implants may have an undersized diameter along the shaft. This manufacturing defect can cause the implant to break due to fatigue under normal stress. The recall covers 17 different model variants of the Trochanteric and Priformis nails in various lengths and orientations (Right/Left).

Risk

If the implant fractures inside the body, it can lead to severe pain, local tissue damage, and improper healing of the femur (non-union or malunion). These complications typically require an invasive surgical procedure to remove and replace the broken device.

What You Should Do

This recall affects Affixus Antegrade Femoral Nails sold under the Affixus Antegrade Femoral Nailing System brand, including model numbers 815509320, 815509340, 815509360, 815509380, 815509400, 815509420, 815509440, 815609300, 815609320, 815609340, 815609360, 815609380, 815609400, 815609420, 815609440, 815809280, and 815509300. See the Affected Products section below for the full list of affected codes.
Medical facilities and surgeons should stop using the recalled implants and immediately quarantine any remaining stock.
Contact Zimmer, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected devices.
For additional information regarding this recall, call the FDA at 1-888-463-6332.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Affixus Antegrade Femoral Nails (320 mm Right Trochanteric)

Variants: 9 mm, Length 320 mm, Right, Trochanteric

Model / REF:

815509320

Lot Numbers:

66717551

66884561

UDI:

00887868143526

Product: Affixus Antegrade Femoral Nails (340 mm Right Trochanteric)

Variants: 9 mm, Length 340 mm, Right, Trochanteric

Model / REF:

815509340

Lot Numbers:

66717552

66884562

UDI:

00887868143533

Product: Affixus Antegrade Femoral Nails (360 mm Right Trochanteric)

Variants: 9 mm, Length 360 mm, Right, Trochanteric

Model / REF:

815509360

Lot Numbers:

66717553

66884563

UDI:

00887868143540

Product: Affixus Antegrade Femoral Nails (380 mm Right Trochanteric)

Variants: 9 mm, Length 380 mm, Right, Trochanteric

Model / REF:

815509380

Lot Numbers:

66717554

66884564

67042197

UDI:

00887868143557

Product: Affixus Antegrade Femoral Nails (400 mm Right Trochanteric)

Variants: 9 mm, Length 400 mm, Right, Trochanteric

Model / REF:

815509400

Lot Numbers:

66717555

66884565

67379212

UDI:

00887868143564

Product: Affixus Antegrade Femoral Nails (420 mm Right Trochanteric)

Variants: 9 mm, Length 420 mm, Right, Trochanteric

Model / REF:

815509420

Lot Numbers:

66717556

66884566

UDI:

00887868143571

Product: Affixus Antegrade Femoral Nails (440 mm Right Trochanteric)

Variants: 9 mm, Length 440 mm, Right, Trochanteric

Model / REF:

815509440

Lot Numbers:

66717557

67101279

67101280

UDI:

00887868143588

Product: Affixus Antegrade Femoral Nails (300 mm Left Trochanteric)

Variants: 9 mm, Length 300 mm, Left, Trochanteric

Model / REF:

815609300

Lot Numbers:

66717600

UDI:

00887868144462

Product: Affixus Antegrade Femoral Nails (320 mm Left Trochanteric)

Variants: 9 mm, Length 320 mm, Left, Trochanteric

Model / REF:

815609320

Lot Numbers:

66717601

66892900

UDI:

00887868144479

Product: Affixus Antegrade Femoral Nails (340 mm Left Trochanteric)

Variants: 9 mm, Length 340 mm, Left, Trochanteric

Model / REF:

815609340

Lot Numbers:

66717602

66892901

UDI:

00887868144486

Product: Affixus Antegrade Femoral Nails (360 mm Left Trochanteric)

Variants: 9 mm, Length 360 mm, Left, Trochanteric

Model / REF:

815609360

Lot Numbers:

66717603

66892902

67031550

UDI:

00887868144493

Product: Affixus Antegrade Femoral Nails (380 mm Left Trochanteric)

Variants: 9 mm, Length 380 mm, Left, Trochanteric

Model / REF:

815609380

Lot Numbers:

66717604

66892903

UDI:

00887868144509

Product: Affixus Antegrade Femoral Nails (400 mm Left Trochanteric)

Variants: 9 mm, Length 400 mm, Left, Trochanteric

Model / REF:

815609400

Lot Numbers:

66717605

66892904

67031552

UDI:

00887868144516

Product: Affixus Antegrade Femoral Nails (420 mm Left Trochanteric)

Variants: 9 mm, Length 420 mm, Left, Trochanteric

Model / REF:

815609420

Lot Numbers:

66717606

66892905

UDI:

00887868144523

Product: Affixus Antegrade Femoral Nails (440 mm Left Trochanteric)

Variants: 9 mm, Length 440 mm, Left, Trochanteric

Model / REF:

815609440

Lot Numbers:

66717607

67031553

UDI:

00887868144530

Product: Affixus Antegrade Femoral Nails (280 mm Left Priformis)

Variants: 9 mm, Length 280 mm, Left, Priformis

Model / REF:

815809280

Lot Numbers:

67066287

UDI:

00887868584763

Product: Affixus Antegrade Femoral Nails (300 mm Right Trochanteric)

Variants: 9 mm, Length 300 mm, Right, Trochanteric

Model / REF:

815509300

Lot Numbers:

66717550

UDI:

00887868143519

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98069

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: Authorized medical device distributors; Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 17 products (22; 22; 22; 23; 23; 22; 22; 11; 23; 24; 24; 24; 24; 23; 24; 3; 11)

Distributed To: Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Affixus Antegrade Femoral Nails sold under the Affixus Antegrade Femoral Nailing System brand, including model numbers 815509320, 815509340, 815509360, 815509380, 815509400, 815509420, 815509440, 815609300, 815609320, 815609340, 815609360, 815609380, 815609400, 815609420, 815609440, 815809280, and 815509300. See the Affected Products section below for the full list of affected codes.

Medical facilities and surgeons should stop using the recalled implants and immediately quarantine any remaining stock.

Contact Zimmer, Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected devices.

For additional information regarding this recall, call the FDA at 1-888-463-6332.

Affected Products

Product: Affixus Antegrade Femoral Nails (320 mm Right Trochanteric)

Variants: 9 mm, Length 320 mm, Right, Trochanteric

Model / REF:

815509320

Lot Numbers:

66717551

66884561

UDI:

00887868143526

Product: Affixus Antegrade Femoral Nails (340 mm Right Trochanteric)

Variants: 9 mm, Length 340 mm, Right, Trochanteric

Model / REF:

815509340

Lot Numbers:

66717552

66884562

UDI:

00887868143533

Product: Affixus Antegrade Femoral Nails (360 mm Right Trochanteric)

Variants: 9 mm, Length 360 mm, Right, Trochanteric

Model / REF:

815509360

Lot Numbers:

66717553

66884563

UDI:

00887868143540

Product: Affixus Antegrade Femoral Nails (380 mm Right Trochanteric)

Variants: 9 mm, Length 380 mm, Right, Trochanteric

Model / REF:

815509380

Lot Numbers:

66717554

66884564

67042197

UDI:

00887868143557

Product: Affixus Antegrade Femoral Nails (400 mm Right Trochanteric)

Variants: 9 mm, Length 400 mm, Right, Trochanteric

Model / REF:

815509400

Lot Numbers:

66717555

66884565

67379212

UDI:

00887868143564

Product: Affixus Antegrade Femoral Nails (420 mm Right Trochanteric)

Variants: 9 mm, Length 420 mm, Right, Trochanteric

Model / REF:

815509420

Lot Numbers:

66717556

66884566

UDI:

00887868143571

Product: Affixus Antegrade Femoral Nails (440 mm Right Trochanteric)

Variants: 9 mm, Length 440 mm, Right, Trochanteric

Model / REF:

815509440

Lot Numbers:

66717557

67101279

67101280

UDI:

00887868143588

Product: Affixus Antegrade Femoral Nails (300 mm Left Trochanteric)

Variants: 9 mm, Length 300 mm, Left, Trochanteric

Model / REF:

815609300

Lot Numbers:

66717600

UDI:

00887868144462

Product: Affixus Antegrade Femoral Nails (320 mm Left Trochanteric)

Variants: 9 mm, Length 320 mm, Left, Trochanteric

Model / REF:

815609320

Lot Numbers:

66717601

66892900

UDI:

00887868144479

Product: Affixus Antegrade Femoral Nails (340 mm Left Trochanteric)

Variants: 9 mm, Length 340 mm, Left, Trochanteric

Model / REF:

815609340

Lot Numbers:

66717602

66892901

UDI:

00887868144486

Product: Affixus Antegrade Femoral Nails (360 mm Left Trochanteric)

Variants: 9 mm, Length 360 mm, Left, Trochanteric

Model / REF:

815609360

Lot Numbers:

66717603

66892902

67031550

UDI:

00887868144493

Product: Affixus Antegrade Femoral Nails (380 mm Left Trochanteric)

Variants: 9 mm, Length 380 mm, Left, Trochanteric

Model / REF:

815609380

Lot Numbers:

66717604

66892903

UDI:

00887868144509

Product: Affixus Antegrade Femoral Nails (400 mm Left Trochanteric)

Variants: 9 mm, Length 400 mm, Left, Trochanteric

Model / REF:

815609400

Lot Numbers:

66717605

66892904

67031552

UDI:

00887868144516

Product: Affixus Antegrade Femoral Nails (420 mm Left Trochanteric)

Variants: 9 mm, Length 420 mm, Left, Trochanteric

Model / REF:

815609420

Lot Numbers:

66717606

66892905

UDI:

00887868144523

Product: Affixus Antegrade Femoral Nails (440 mm Left Trochanteric)

Variants: 9 mm, Length 440 mm, Left, Trochanteric

Model / REF:

815609440

Lot Numbers:

66717607

67031553

UDI:

00887868144530

Product: Affixus Antegrade Femoral Nails (280 mm Left Priformis)

Variants: 9 mm, Length 280 mm, Left, Priformis

Model / REF:

815809280

Lot Numbers:

67066287

UDI:

00887868584763

Product: Affixus Antegrade Femoral Nails (300 mm Right Trochanteric)

Variants: 9 mm, Length 300 mm, Right, Trochanteric

Model / REF:

815509300

Lot Numbers:

66717550

UDI:

00887868143519

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98069

Status: Active

Manufacturer: Zimmer, Inc.

Sold By: Authorized medical device distributors; Hospitals; Surgical centers

Manufactured In: United States

Units Affected: 17 products (22; 22; 22; 23; 23; 22; 22; 11; 23; 24; 24; 24; 24; 23; 24; 3; 11)

Distributed To: Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, North Carolina, New Mexico, Rhode Island, Texas, Utah