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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
SpheRx® Posted Pedicle Screw System		see related information
Date Posted November 19, 2012
Recall Number Z-0364-2013
Product 7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Code Information Batch: JK2099, JK2186
Recalling Firm/
Manufacturer		 NuVasive Inc
7475 Lusk Blvd
San Diego, California 92121-5707
Reason for
Recall		 The tulip portion of the screw assembly can disengage from the shank after implantation.
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.
 
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