FDA Device recall Z-2835-2016
FPS 35mm x 3.5 mm non-locking screw
- FDA Device
- Class II
- terminated
- Published 2016-09-28
On 2016-09-28 the FDA classified a Class II recall of FPS 35mm x 3.5 mm non-locking screw by Ortho Solutions, citing mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2835-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-21 |
| Published | 2016-09-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Solutions |
| Distribution | n/a |
Product
FPS 35mm x 3.5 mm non-locking screw
Reason
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
Identifiers
| code_info | Part number - OS326835 Lot number: 10100/269A12-68051 |
|---|
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-2835-2016%22
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