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U.S. Department of Health and Human Services

Class 2 Device Recall neon3 OCT spinal stabilization

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  Class 2 Device Recall neon3 OCT spinal stabilization see related information
Date Initiated by Firm December 31, 2019
Create Date March 02, 2020
Recall Status1 Open3, Classified
Recall Number Z-1350-2020
Recall Event ID 84638
510(K)Number K150650  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Code Information Lot Numbers: U010577, U016620, U019084
Recalling Firm/
Manufacturer		 ulrich medical USA Inc
18221 Edison Ave
Chesterfield MO 63005-3703
For Additional Information Contact
636-519-0268
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action Ulrich notified initially notified customers, via phone call, on 12/20/2019. On about 12/31/2019, customers were also sent an official "URGENT SAFETY INFORMATION: MEDICAL DEVICE CORRECTIONS & REMOVALS" letter. Customers were informed that the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. Instructions included cease use of the affected devices, return them to Ulrich, and complete and return the provided "Product Recall" form. Customers were also instructed to inform all users of the devices within each organization are informed. Questions or concerns can be directed to Mr. Louis Milos, Sr. Manager Business and Quality Systems, at 636-519-0268 ext. 105, l.milos@ulrichmedicalusa.com, Monday through Friday 8:00am to 5:00pm CST.
Quantity in Commerce 179 units
Distribution AZ, TX, GA, FL, AR, CA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = ULRICH GMBH & CO. KG
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