Class 2 Device Recall Rejuvenate Modular Stems

• Date Initiated by Firm: April 30, 2012
• Date Posted: July 26, 2012
• Recall Status: Open, Classified
• Recall Number: Z-2090-2012
• Recall Event ID: 62456
• 510(K)Number: K092561
• Product Classification: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
• Product: Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
• Code Information: 510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Ms. Colleen O'Meara; 201-972-2100
• Manufacturer Reason for Recall: Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an
• FDA Determined Cause: Device Design
• Action: Stryker sent an "URGENT PRODUCT CORRECTION" letter dated April 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Product Correction Acknowledgment Form for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-831-5970 for questions regarding this notice. Stryker sent and "Urgent Update Product Recall" Letter dated January 3, 2013 to all affected customers. The new letter includes updated corrective actions for patients. Another letter was sent out on 7/25/2014.
• Quantity in Commerce: (NLS/NLV) - 23193 units and (SPT) - 20,743 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MEH