Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 14, 2015
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho Solutions Inc recalled Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 Wes… - a moderate-severity action.
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 Wes… was recalled by Ortho Solutions Inc in October 14, 2015. Reason: Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature…. Check the official notice for the remedy. Verify recall #Z-0026-2016 with the FDA Devices before acting.
The recall
Ortho Solutions Inc issued this moderate-severity FDA Devices recall-Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature….
- Moderate
- severity level
- 875 units
- affected scope
- Class II
- classification
- October 14, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0026-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0026-2016) was formally reported on October 14, 2015, with the manufacturer initiating the action on July 14, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho Solutions Inc is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 875 units.
The documented reason for this recall is: 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 lo… Distribution data in the federal record shows the product reached: US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
875 units
Related Recalls
6
3 from same agency
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0026-2016 |
| Date reported | October 14, 2015 |
| Date initiated | July 14, 2015 |
| Recalling firm | Ortho Solutions Inc |
| Firm location | Mahwah, NJ |
| Affected scope | 875 units |
| Distribution | US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0026-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ortho Solutions Inc. Units affected: 875 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2015. Severity: Moderate. Recall number: Z-0026-2016.
Where was the recalled product distributed? ▼
Distribution: US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0026-2016) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 14, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.