FDA Device recall Z-0143-2019
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures by Zimmer Biomet, citing there were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0143-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-08 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Affixus Hip Fracture Nail Right 125 13 mm x 400 mm, Item Number 814313400 Product Usage: Intended for the fixation of fractures
Reason
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Identifiers
| code_info | Lot Numbers: 584890 |
|---|
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-0143-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.