Class II — Ortho Solutions Inc
| Recalling firm | ORTHO SOLUTIONS INC |
|---|---|
| Registered facility | Ortho Solutions Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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 |
| Quantity | 875 units |
| Distribution | US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA. |
| Initiated | 2015-07-14 |
| Classified | 2015-10-06 |
| Terminated | 2017-04-26 |
| Recall number | Z-0026-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ortho Solutions Inc (Z-0026-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71899/
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