Ulrich Medical Recalls uNion Cervical Plate System for Screw Mechanism Defect
Ulrich Medical USA Inc is recalling 4,854 uNion Cervical Plate Systems because static plate screws may disassociate. The recall covers devices distributed in 20 US states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard involves a mechanical defect (screw disassociation) in a spinal implant, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, placing it in the High severity category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ulrich Medical USA Inc is recalling 4,854 units of the uNion Cervical Plate System. This medical device is intended for anterior fixation of the cervical spine (C2 to T1) to provide stabilization as an adjunct to fusion for conditions such as degenerative disc disease, spondylolisthesis, trauma, tumors, spinal stenosis, deformity, pseudarthrosis, or failed previous fusion.
The recall was initiated because the surgical technique was revised to prevent static plate screws from disassociating. This defect involves the blocking mechanisms of the static plate screws. The affected devices were distributed nationwide in the United States, specifically in the states of Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Missouri, Mississippi, New York, Ohio, Oklahoma, Oregon, Tennessee, Texas, and Wisconsin.
Healthcare providers and patients should contact Ulrich Medical USA Inc for further instructions regarding the recall. The source text does not specify a particular action for consumers beyond the general recall context, but the revision of surgical technique implies that the defect is addressed through procedural changes rather than a specific consumer remediation step like disposal or return.
The recalled product
- Product
- 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 degener
- Manufacturer
- Ulrich Medical USA Inc
- Affected units
- 4,854
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 043605
- U010751
- U010759
- U011072
- U012021
- U012022
- U012885
- 043606
- U010752
- U010760
- U012023
- U012886
- 043607
- U010753
- U010761
- U012024
- U012887
- 043608
- U010754
- U010762
Distribution
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