Class 2 Device Recall MaxLock Screwdriver

• Date Initiated by Firm: November 01, 2005
• Date Posted: March 09, 2006
• Recall Status: Terminated on April 25, 2012
• Recall Number: Z-0598-06
• Recall Event ID: 34498
• Product Classification: Plate, Fixation, Bone - Product Code HRS
• Product: MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
• Code Information: lot #11298
• FEI Number: 3000718467
• Recalling Firm/ Manufacturer: Orthohelix Surgical Designs Inc; 1815 W Market Street; Suite 205; Akron OH 44313
• For Additional Information Contact: Lee A. Strand; 800-904-3549
• Manufacturer Reason for Recall: Screwdriver pilot taper tip can break during surgery.
• FDA Determined Cause: Other
• Action: Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.
• Quantity in Commerce: 14
• Distribution: Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.
• 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.