Class 2 Device Recall

• Date Initiated by Firm: September 07, 2004
• Date Posted: December 01, 2005
• Recall Status: Terminated on October 03, 2006
• Recall Number: Z-0256-06
• Recall Event ID: 31986
• 510(K)Number: K013468
• Product Classification: Nail, Fixation, Bone, Metallic - Product Code NDH
• Product: Long Length Dyax Nail.
• Code Information: Catalog No. 1594-4430S Lot K559623
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Dominick Cristofolo; 201-831-5247
• Manufacturer Reason for Recall: Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.
• FDA Determined Cause: Other
• Action: The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.
• Quantity in Commerce: 4
• Distribution: The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.
• 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 = NDH