uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cerv
FDA device recall Z-1878-2017 · posted 2017-04-26 · Terminated
Recall details
- Recalling firm
- Ulrich Medical USA Inc
- Reason for recall
- Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
- Action taken
- On March 7, 2017, the recalling firm sent letters by mail informing customers of the field correction along with the updated surgical technique which contains the enhanced cautionary statement. Customers were instructed to destroy older versions of the surgical technique. The letters also contained a link to the recalling firm's website on which the recalling firm posted the current, updated copy of the surgical technique.
- Root cause
- Use error
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 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
- Date initiated
- 2017-03-07
- Date posted
- 2017-04-26
- Date terminated
- 2017-11-30
- Location
- Chesterfield, MO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| uNion Cervical Plate System (K150666) | Ulrich Medical USA | 2015-06-22 |