Class 2 Device Recall Reflex Revision Screwdriver Inner Shaft

• Date Initiated by Firm: June 05, 2008
• Date Posted: September 19, 2008
• Recall Status: Terminated on September 22, 2008
• Recall Number: Z-2238-2008
• Recall Event ID: 48699
• Product Classification: Orthopedic manual surgical instrument, screwdriver - Product Code HXX
• Product: Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile
• Code Information: Lot codes: 26719, 047377, 047570, 065167, 06A167, and 072689.
• Recalling Firm/ Manufacturer: Stryker Spine; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Michelle Klein; 201-760-8256
• Manufacturer Reason for Recall: The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw.
• FDA Determined Cause: Process control
• Action: URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008. If you have questions, contact Michelle Klein at 201-760-8256.
• Quantity in Commerce: 35
• Distribution: The product was distributed to 13 Stryker branches/agencies.
• 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.