HIGH

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer, Inc. recalled 11 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, posing a risk of fatigue fracture. This defect could cause adverse reactions requiring surgical intervention.

Quick Facts at a Glance

Recall Date
December 2, 2025
Hazard Level
HIGH
Brand
Zimmer
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zimmer, Inc. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the Affixus Antegrade Femoral Nails, Model 815509300. It consists of a 9 mm diameter nail, 300 mm in length, designed for surgical applications. The affected units were distributed nationwide in several states including California and Florida.

The Hazard

The implants may have an undersized distal diameter along the shaft, leading to implant fatigue fractures. This condition could result in adverse local tissue reactions, pain, or the need for additional surgical procedures.

Reported Incidents

There are no reported incidents of injury or death related to this recall. However, potential health risks include pain, non-union or malunion of the bone, and tissue damage.

What to Do

Patients and healthcare providers should immediately stop using the affected devices. Follow the recall instructions provided by Zimmer, Inc. and contact your healthcare provider for further guidance.

Contact Information

For more information, contact Zimmer, Inc. at their customer service number or visit their website for details on the recall.

Key Facts

  • Recall date: December 2, 2025
  • Quantity recalled: 11 units
  • Potential risks include surgical intervention
  • Affected devices distributed nationwide

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
Lot Code: Model No 815509300
UDI-DI (01)00887868143519(17)340823(10)66717550
Lot Number 66717550
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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