Class 2 Device Recall Stryker Orthopaedics Rim Impactor Tip

• Date Initiated by Firm: September 30, 2013
• Date Posted: December 27, 2013
• Recall Status: Terminated on October 19, 2016
• Recall Number: Z-0582-2014
• Recall Event ID: 66909
• Product Classification: Impactor - Product Code HWA
• Product: Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
• Code Information: Catalog number 12350-013 all lot codes
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2002
• For Additional Information Contact: Ms. Colleen O'Meara; 201-831-5970
• Manufacturer Reason for Recall: Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
• FDA Determined Cause: Device Design
• Action: Stryker sent an Urgent Medical Device Correction letter dated October 1, 2013 to all affected customers via Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax the attached Product Correction Acknowledgement form to 855-251-3635.
• Quantity in Commerce: 1,690 units
• Distribution: USA 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.