FDA Device recall Z-0130-2019
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number 814311460 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 9 mm x 460 mm, Item Number 814311460 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-0130-2019 |
| 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 9 mm x 460 mm, Item Number 814311460 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: 369120 |
|---|
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-0130-2019%22
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