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-0975-2026
- 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
- Device Malfunction
- 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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand 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
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
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 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 66892900
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 98069This product is part of a recall event; the main page for the event is Affixus Antegrade Femoral Nailing System Affixus Antegrade recalled.
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|---|---|---|---|---|---|
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| Device | CLASS II | Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment recalled | Zimmer | Packaging Defects | IN |
| Device | CLASS II | Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide recalled | Zimmer | Foreign Material | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |