CLASS II Device recall · Reported 19 Sep 2018 · FDA Enforcement Report
Affixus¿ Hip Fracture Nail Left 125¿ recalled by Zimmer Biomet
Zimmer Biomet is recalling Affixus¿ Hip Fracture Nail Left 125¿, distributed in 42 states. The recall was initiated on 17 Jul 2018 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-3104-2018
- FDA event ID
- 80755
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2018
- FDA classified
- 13 Sep 2018
- Reported
- 19 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 17 Jul 2018 | Recall initiated by company | |
| 13 Sep 2018 | Classified by FDA | +58 days |
| 19 Sep 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The set screw is not able to advance or reverse from the original position in the nail.
Product as listed by the FDA
Affixus¿ Hip Fracture Nail Left 125¿ 13 mm x 380 mm, Item Number: 814413380
Where it was distributed
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
The set screw is not able to advance or reverse from the original position in the nail.
Which lots are affected?
417480 646660
Where was it sold?
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, and Puerto Rico. The products were distributed to the following foreign countries: Chile, Ecuador, Japan, Netherlands.
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
100 other products · FDA event 80755This product is part of a recall event; the main page for the event is Affixus¿ Hip Fracture Nail Right 125¿ recalled by Zimmer Biomet.
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|---|---|---|---|---|---|
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| Device | CLASS II | Bearing And Axle Bushing Assy Std Elbow C-m113-1-301 Krh recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio + Mobile Bearing Pcs 78-5-0910 System One Bipolar recalled | Howmedica Osteonics | Other | Nationwide |