FDA Device recall Z-3128-2018
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400
- FDA Device
- Class II
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class II recall of Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400 by Zimmer Biomet, citing the set screw is not able to advance or reverse from the original position in the nail.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3128-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-17 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | 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 |
Product
Affixus¿ Hip Fracture Nail Right 130¿ 11 mm x 400 mm, Item Number: 814511400
Reason
The set screw is not able to advance or reverse from the original position in the nail.
Identifiers
| code_info | 054240 054250 154980 472860 773390 798600 798610 017490 245530 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3128-2018%22
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