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Lower risk Medical device recall · FDA · Published December 2, 2025

Zimmer Affixus Femoral Nails Recall: Risk of Fracture from Undersized Diameter

Zimmer recalls Affixus Antegrade Femoral Nails with possible undersized diameter that may cause fractures. Affected implants could lead to pain, surgery, or tissue damage. Check model numbers 815509420 and lot numbers 66717556 or 66884566.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0972-2026Medical deviceZimmer ›
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Contact the company

Recalling firmZimmer, Inc.1800 W Center St · Warsaw, IN 46580-2304
✎ GovInfoNow plain-language explainer

Zimmer is recalling Affixus Antegrade Femoral Nails that may have undersized diameter, increasing the risk of fractures. This could cause pain, surgery, or tissue damage if the implant breaks. Read more at govinfonow.com/recall/50551-zimmer-affixus-femoral-nails-recall-risk-of-fracture-from-undersized.

Source Summary by GovInfoNow · govinfonow.com/recall/50551-zimmer-affixus-femoral-nails-recall-risk-of-fracture-from-undersized · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0972-2026

Cite this page

“Zimmer Affixus Femoral Nails Recall: Risk of Fracture from Undersized Diameter.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50551-zimmer-affixus-femoral-nails-recall-risk-of-fracture-from-undersized. Based on FDA recall #Z-0972-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0972-2026%22&limit=1).

The FDA announced on Dec. 2, 2025, that Zimmer, Inc. is recalling Affixus Antegrade Femoral Nails due to a potential implant fatigue fracture hazard. The agency issued recall number Z-0972-2026 for the Class II device.

How to tell if you have it

  • Brand: Zimmer
  • Product Name: Affixus Antegrade Femoral Nails
  • Model/Catalog Number: 815509420
  • UPC: 00887868143571
  • Lot Numbers: 66717556, 66884566

The hazard

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

Context

GovInfoNow's records show Zimmer, Inc. has 19 other recalls on record since Aug. 25, 2022. Other recent recalls of similar products include the Straumann Bone Level Tapered Implant (July 16, 2026), Howmedica OMNIFIT Series I Acetabular Insert (July 30, 2026), and Acumed Hexalob Screw (May 28, 2026).

How to tell if you have this one

Check for model number 815509420 and lot numbers 66717556 or 66884566 on the implant packaging or documentation.

  • Brand
    Zimmer
  • Product
    Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog
  • Category
    Medical device
FDA recall event · 17 products

All 17 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Recall numberProduct, codes & lotsQuantity
Z-0967-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509320 ; UDI-DI (01)00887868143526(17)340820(10)66717551 ; Lot Number 66717551 Model No 815509320 ; UDI-DI (01)00887868143526(17)340821(10)66884561; Lot Number 6688456122
Z-0968-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509340 ; UDI-DI (01)00887868143533(17)340822(10)66717552 ; Lot Number 66717552 Model No 815509340 ; UDI-DI (01)00887868143533(17)340826(10)66884562 ; Lot Number 6688456222
Z-0969-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509360 ; UDI-DI (01)00887868143540(17)340917(10)66717553 ; Lot Number 66717553 Model No 815509360 ; UDI-DI (01)00887868143540(17)340823(10)66884563 ; Lot Number 6688456322
Z-0970-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66717554 ; Lot Number 66717554 Model No 815509380 ; UDI-DI (01)00887868143557(17)340822(10)66884564 ; Lot Number 66884564 Model No 815509380 ; UDI-DI (01)00887868143557(17)350421(10)67042197 ; Lot Number 6704219723
Z-0971-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509400 Software Version: N/A Product Description: Affixus 9 mm, Length 400 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509400 ; UDI-DI (01)00887868143564(17)340821(10)66717555 ; Lot Number 66717555 Model No 815509400 ; UDI-DI (01)00887868143564(17)340822(10)66884565 ; Lot Number 66884565 Model No 815509400 ; UDI-DI (01)00887868143564(17)350801(10)67379212 ; Lot Number 6737921223
Z-0972-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420 Software Version: N/A Product Description: Affixus 9 mm, Length 420 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66717556 ; Lot Number 66717556 Model No 815509420 ; UDI-DI (01)00887868143571(17)340920(10)66884566 ; Lot Number 6688456622
Z-0973-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509440 ; UDI-DI (01)00887868143588(17)340820(10)66717557 ; Lot Number 66717557 Model No 815509440 ; UDI-DI (01)00887868143588(17)350422(10)67101279 ; Lot Number 67101279 Model No 815509440 ; UDI-DI (01)00887868143588(17)350419(10)67101280 ; Lot Number 6710128022
Z-0974-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Left, Trochanteric Nail Component: N/A; Lot Code: Model No 815609300 ; UDI-DI (01)00887868144462(17)340826(10)66717600 ; Lot Number 6671760011
Z-0975-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609320 Software Version: N/A Product Description: Affixus 9 mm, Length 320 mm, Left, Trochanteric Nail Component: N/A; Lot Code: Model No 815609320 ; UDI-DI (01)00887868144479(17)340826(10)66717601 ; Lot Number 66717601 Model No 815609320 ; UDI-DI (01)00887868144479(17)340820(10)66892900 ; Lot Number 6689290023
Z-0976-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: N/A Product Description: Affixus 9 mm, Length 340 mm, Left, Trochanteric Nail Component: N/A; Lot Code: Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66717602 ; Lot Number 66717602 Model No 815609340 ; UDI-DI (01)00887868144486(17)340904(10)66892901 ; Lot Number 6689290124
Z-0977-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609360 Software Version: N/A Product Description: Affixus 9 mm, Length 360 mm, Left, Trochanteric Nail Component: N/A; Lot Code: Model No 815609360 ; UDI-DI (01)00887868144493(17)340820(10)66717603 ; Lot Number 66717603 Model No 815609360 ; UDI-DI (01)00887868144493(17)340905(10)66892902 ; Lot Number 66892902 Model No 815609360 ; UDI-DI (01)00887868144493(17)341030(10)67031550 ; Lot Number 6703155024
Z-0978-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609380 Software Version: N/A Product Description: Affixus 9 mm, Length 380 mm, Left, Trochanteric Nail Component: N/A; Lot Code: Model No 815609380 ; UDI-DI (01)00887868144509(17)340826(10)66717604 ; Lot Number 66717604 Model No 815609380 ; UDI-DI (01)00887868144509(17)340820(10)66892903 ; Lot Number 6689290324
Z-0979-2026Brand 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; Lot Code: Model No 815609400 ; UDI-DI (01)00887868144516(17)340818(10)66717605 ; Lot Number 66717605 Model No 815609400 ; UDI-DI (01)00887868144516(17)340826(10)66892904 ; Lot Number 66892904 Model No 815609400 ; UDI-DI (01)00887868144516(17)341024(10)67031552 ; Lot Number 6703155224
Z-0980-2026Brand 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; Lot Code: Model No 815609420 ; UDI-DI (01)00887868144523(17)340818(10)66717606 ; Lot Number 66717606 Model No 815609420 ; UDI-DI (01)00887868144523(17)340913(10)66892905 ; Lot Number 6689290523
Z-0981-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609440 Software Version: N/A Product Description: Affixus 9 mm, Length 440 mm, Left, Trochanteric Nail Component: N/A; Lot Code: Model No 815609440 ; UDI-DI (01)00887868144530(17)340819(10)66717607; Lot Number 66717607 Model No 815609440 ; UDI-DI (01)00887868144530(17)341025(10)67031553 ; Lot Number 6703155324
Z-0982-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815809280 Software Version: N/A Product Description: Affixus 9 mm, Length 280 mm, Left, Priformis Nail Component: N/A; Lot Code: Model No 815809280 ; UDI-DI (01)00887868584763(17)350416(10)67066287 ; Lot Number 670662873
Z-0983-2026Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509300 Software Version: N/A Product Description: Affixus 9 mm, Length 300 mm, Right, Trochanteric Nail Component: N/A; Lot Code: Model No 815509300 ; UDI-DI (01)00887868143519(17)340823(10)66717550 ; Lot Number 6671755011
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Details

    Look for model number 815509420 and lot numbers 66717556 or 66884566 on the implant packaging or documentation.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 14 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: named in the noticeALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Florida, Indiana, Kentucky, Massachusetts, Missouri, Montana, New Mexico, North Carolina, Rhode Island, Texas, Utah.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Dec 2, 202512. FDA classified it Class II: Dec 22, 202523. Published in FDA’s Enforcement Report: Dec 31, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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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-0972-2026 (December 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0972-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA