Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 3, 2017
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Ulrich Medical USA Inc recalled uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intende… - a moderate-severity action.
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intende… was recalled by Ulrich Medical USA Inc in May 3, 2017. Reason: Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.. Check the official notice for the remedy. Verify recall #Z-1878-2017 with the FDA Devices before acting.
The recall
Ulrich Medical USA Inc issued this moderate-severity FDA Devices recall-Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating..
- Moderate
- severity level
- Class II
- classification
- May 3, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1878-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1878-2017) was formally reported on May 3, 2017, with the manufacturer initiating the action on March 7, 2017. 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 4,854 plates.
The documented reason for this recall is: Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating. Distribution data in the federal record shows the product reached: US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI. 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
4,854 plates
Related Recalls
6
3 from same agency
Product description
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Reason for recall
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1878-2017 |
| Date reported | May 3, 2017 |
| Date initiated | March 7, 2017 |
| Recalling firm | Ulrich Medical USA Inc |
| Firm location | Chesterfield, MO |
| Affected scope | 4,854 plates |
| Distribution | US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI |
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-1878-2017) 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? ▼
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.. Recalled by Ulrich Medical USA Inc. Units affected: 4,854 plates.
Why was this product recalled? ▼
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 3, 2017. Severity: Moderate. Recall number: Z-1878-2017.
Where was the recalled product distributed? ▼
Distribution: US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1878-2017) 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 May 3, 2017. 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.