Ortho OS Solutions UltOS 3 — Class II medical device recall Z-0026-2016
Terminated recall by Ortho Solutions Inc, reported 2015-10-14, distributed in CA, CO, GA, IL, LA, NC, NY, TX…. Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature
| Recall number | Z-0026-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Solutions Inc, Mahwah, NJ, United States |
| Recall initiated | 2015-07-14 |
| Classified | 2015-10-06 |
| Reported by FDA | 2015-10-14 |
| Terminated | 2017-04-26 |
| Distributed | CA, CO, GA, IL, LA, NC, NY, TX, WA |
| Quantity | 875 units |
| Lot numbers | 7519, 7520, 7891 |
Product
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Reason for recall
Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ
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-0026-2016. 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.