Class 2 Device Recall Solanas

• Date Initiated by Firm: August 05, 2009
• Date Posted: December 14, 2009
• Recall Status: Terminated on June 07, 2010
• Recall Number: Z-0502-2010
• Recall Event ID: 53144
• 510(K)Number: K052201 K071380
• Product Classification: Pedicle Screw - Product Code KWP
• Product: Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
• Code Information: Lot Numbers: 624239, 624240
• FEI Number: 2027467
• Recalling Firm/ Manufacturer: Alphatec Spine, Inc.; 5818 El Camino Real; Carlsbad CA 92008-8816
• For Additional Information Contact: 760-494-9286
• Manufacturer Reason for Recall: Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
• FDA Determined Cause: Process control
• Action: Alphatec Spine telephoned consignees informing them of the above mentioned Public Reason for Recall on August 5, 2009. They were asked to check their inventory to see where this product is located. If the product had not already been used Alphatec arranged to have Federal Express contact consignee for pick-up of the product(s). They were told to expect to receive the replacement(s) within 2-3 days.
• Quantity in Commerce: 163 Units
• Distribution: Nationwide distribution.
• 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 = KWP