| Class 2 Device Recall SpheRx Posted Pedicle Screw System | |
Date Initiated by Firm | January 05, 2009 |
Date Posted | November 19, 2012 |
Recall Status1 |
Terminated 3 on November 19, 2012 |
Recall Number | Z-0356-2013 |
Recall Event ID |
52634 |
510(K)Number | K082332 |
Product Classification |
Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
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Product | 6.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI |
Code Information |
Batch: JK2083, JK2184 |
Recalling Firm/ Manufacturer |
NuVasive Inc 7475 Lusk Blvd San Diego CA 92121-5707
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For Additional Information Contact | 858-909-1800 Ext. 1868 |
Manufacturer Reason for Recall | The tulip portion of the screw assembly can disengage from the shank after implantation. |
FDA Determined Cause 2 | Device Design |
Action | Telephone communications to the sales representatives of surgeons actively using the Posted Pedicle Screw System were made on 01/05/2009. The calls were unscripted and requested that all inventory be forwarded to NuVasive's San Diego office for quarantine. Surgeons who were actively using the system were also contacted and notified of the situation. Follow-up communications were sent via mail on 01/19/2009 to all surgeons who participated in the Alpha release. The letter informed the customers of the problems identified. Customers were instructed that the recalling firm does not believe any further action is required and they were instructed to monitor the progress of their patients and notify NuVasive if any issues are detected.
Customers with questions or concerns are instructed to contact the firm at (858) 909-1964. |
Quantity in Commerce | 240 units total |
Distribution | Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NKB
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