CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report
Affixus Antegrade Femoral Nailing System Affixus Antegrade recalled
Zimmer is recalling Affixus Antegrade Femoral Nailing System Affixus Antegrade Femoral Nails, distributed nationwide in the US. The recall was initiated on 2 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0977-2026
- FDA event ID
- 98069
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Dec 2025
- FDA classified
- 22 Dec 2025
- Reported
- 31 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Hip & Knee Implants
Timeline
| 2 Dec 2025 | Recall initiated by company | |
| 22 Dec 2025 | Classified by FDA | +20 days |
| 31 Dec 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Brand 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
Where it was distributed
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
Nationwide AlabamaArizonaCaliforniaFloridaIndianaKentuckyMassachusettsMissouriMontanaNorth CarolinaNew MexicoRhode IslandTexasUtah
Questions about this recall
Is Affixus Antegrade Femoral Nailing System Affixus Antegrade Femoral Nails recalled?
Yes. Zimmer recalled Affixus Antegrade Femoral Nailing System Affixus Antegrade Femoral Nails on 2 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-0977-2026.
Why was it recalled?
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.
Which lots are affected?
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 67031550
Where was it sold?
US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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