FPS 35mm x 3 — Class II medical device recall Z-2835-2016
Terminated recall by Ortho Solutions Inc, reported 2016-09-28. Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
| Recall number | Z-2835-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Solutions Inc, Mahwah, NJ, United States |
| Recall initiated | 2016-07-21 |
| Classified | 2016-09-16 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2016-10-12 |
| Quantity | 15 |
| Reason classes | labeling |
| Lot numbers | 10100/269A12-68051 |
| Model numbers | OS326835 |
Product
FPS 35mm x 3.5 mm non-locking screw
Reason for recall
Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
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-2835-2016. 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.