Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm — Class II medical device recall Z-3047-2018
Terminated recall by Zimmer Biomet, Inc., reported 2018-09-19, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. The set screw is not able to advance or reverse from the original position in the nail.
| Recall number | Z-3047-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-07-17 |
| Classified | 2018-09-13 |
| Reported by FDA | 2018-09-19 |
| Terminated | 2020-06-02 |
| Distributed | 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, PR, SC, SD, TN, TX, UT, VA, WA, WI, WY |
| Countries outside the US | CL, EC, JP, NL |
| Quantity | 5,947 total |
| Model numbers | 814309180 |
Product
Affixus¿ Hip Fracture Nail 125¿ 9 mm x 180 mm, Item Number: 814309180
Reason for recall
The set screw is not able to advance or reverse from the original position in the nail.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3047-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.