Reported May 3, 2017 · Terminated
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the…
Ulrich Medical USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ulrich Medical USA Inc · 18221 Edison Ave · Chesterfield, MO · 63005-3703
Is this the product you have?
- uNion
- Cervical Plate System Product UsageThe 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
- Lot codes and dates
194 of 194 codes
043605U010751U010759U011072U012021U012022U012885043606U010752U010760U012023U012886043607U010753U010761U012024U012887043608U010754U010762U012025U012888043609U010755U010763U012026U012889043610U010756U010764U012027U012890043611U010757U010765U012028U012891043612U010758U010766U012029U012892043613U010149U010769U012038U012541U012893043614U010148U010770U012039U012894043615U010147U010771U012040U012895043616U010146
- Amount recalled
- 4,854 plates
Where it was sold
Why it was recalled
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Ulrich Medical USA Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.