Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Statio...
FDA Device Recall #Z-0026-2016 — Class II — July 14, 2015
Recall Summary
| Recall Number | Z-0026-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 14, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho Solutions Inc |
| Location | Mahwah, NJ |
| Product Type | Devices |
| Quantity | 875 units |
Product Description
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
Distribution Pattern
US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.
Lot / Code Information
Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)
Other Recalls from Ortho Solutions Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2780-2017 | Class II | Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 1... | Apr 19, 2017 |
| Z-2835-2016 | Class II | FPS 35mm x 3.5 mm non-locking screw | Jul 21, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.