Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 4, 2020
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
The recall
ulrich medical USA Inc issued this moderate-severity FDA Devices recall — Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably….
- Moderate
- severity level
- 179 units
- affected scope
- Class II
- classification
- March 4, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1350-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1350-2020) was formally reported on March 4, 2020, with the manufacturer initiating the action on December 31, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. ulrich medical USA Inc is listed as the recalling firm, operating out of Chesterfield, MO. Federal records list the affected scope as 179 units.
The documented reason for this recall is: Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. Distribution data in the federal record shows the product reached: AZ, TX, GA, FL, AR, CA. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Affected scope
179 units
Related Recalls
6
6 from same agency
Product description
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Reason for recall
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1350-2020 |
| Date reported | March 4, 2020 |
| Date initiated | December 31, 2019 |
| Recalling firm | ulrich medical USA Inc |
| Firm location | Chesterfield, MO |
| Affected scope | 179 units |
| Distribution | AZ, TX, GA, FL, AR, CA |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw. Recalled by ulrich medical USA Inc. Units affected: 179 units.
Why was this product recalled? ▼
Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1350-2020.
Where was the recalled product distributed? ▼
Distribution: AZ, TX, GA, FL, AR, CA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1350-2020) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported March 4, 2020.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).