Class 2 Device Recall Spinal fixation system

• Date Initiated by Firm: August 10, 2004
• Date Posted: September 08, 2004
• Recall Status: Terminated on November 29, 2005
• Recall Number: Z-1438-04
• Recall Event ID: 29872
• 510(K)Number: K020279 K024096 K031585 K031595
• Product Classification: Orthosis, Spinal Pedicle Fixation - Product Code MNI
• Product: Optima Spinal System and Spinal Hook System, set screw component.
• Code Information: Part number SP3020 (revision 6), Lot # 04D033.
• Recalling Firm/ Manufacturer: U&I America; 6132 S 380 W Ste 200; Murray UT 84107-6988
• For Additional Information Contact: 952-746-8080 Ext. 234
• Manufacturer Reason for Recall: Threads on a set screw, as a component of a spinal fixation system, may break off during use.
• FDA Determined Cause: Other
• Action: Consignee was notified by letter on 08/10/2004.
• Quantity in Commerce: 200 set screws
• Distribution: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MNI; 510(K)s with Product Code = MNI