Class 2 Device Recall Stryker V40

• Date Initiated by Firm: September 04, 2009
• Date Posted: November 23, 2009
• Recall Status: Terminated on June 26, 2013
• Recall Number: Z-0390-2010
• Recall Event ID: 53434
• 510(K)Number: K010757 K022077 K061434 K993601
• Product Classification: hip prosthesis component. - Product Code JDG
• Product: Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component.
• Code Information: Catalog number 6260-5-326; Lot code 29018201
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: RIchard Wolyn; 201-831-5158
• Manufacturer Reason for Recall: Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
• FDA Determined Cause: Process control
• Action: Stryker sent Notification letters and Product Accountability Forms via FedEx on September 4, 2009 with return receipt. Corrected letters were sent on September 9, 2009.
• Quantity in Commerce: 7 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 = JDG