CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report
Affixus Hip Fracture Nail Left Deg 9x300mm recalled by Zimmer Biomet
Zimmer Biomet is recalling Affixus Hip Fracture Nail Left Deg 9x300mm, distributed nationwide in the US. The recall was initiated on 2 Oct 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-0447-2019
- FDA event ID
- 81223
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Oct 2018
- FDA classified
- 13 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 2 Oct 2018 | Recall initiated by company | |
| 13 Nov 2018 | Classified by FDA | +42 days |
| 21 Nov 2018 | Published in enforcement report | +8 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 Deg 9x300mm, Item Number 814609300 The Affixus Hip Fracture Nail System, comprised of short and long nails, provides surgeons with an intramedullary hip screw to stabilize fractures of the proximal femur.
Where it was distributed
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and Netherlands.
Nationwide 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?
Lot number 371540
Where was it sold?
Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico; and foreign countries of: Chile, Costa Rica, Ecuador and 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
7 other products · FDA event 81223This product is part of a recall event; the main page for the event is Affixus Hip Fracture Nail 125 Deg 12x165mm recalled by Zimmer Biomet.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Affixus Hip Fracture Nail 125 Deg 12x165mm recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide | |
| CLASS II | Affixus Hip Fracture Nail 130 Deg 10x165mm recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide | |
| CLASS II | Affixus Hip Fracture Nail Left 130 Deg 11x300mm recalled | Zimmer Biomet | Other | Nationwide | |
| CLASS II | Affixus Hip Fracture Nail Left 125 Deg 9x165mm recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide | |
| CLASS II | Affixus Hip Fracture Nail Left 125 Deg 11x300mm recalled | Zimmer Biomet | Other | Nationwide | |
| CLASS II | Affixus Hip Fracture Nail 125 Deg 10x165mm recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide | |
| CLASS II | Affixus Hip Fracture Nail 130 Deg 12x165mm recalled by Zimmer Biomet | Zimmer Biomet | Other | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Other | 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 |