Class 2 Device Recall Accolade and Restoration hip product

• Date Initiated by Firm: July 21, 2017
• Create Date: March 09, 2018
• Recall Status: Terminated on March 12, 2020
• Recall Number: Z-0941-2018
• Recall Event ID: 79038
• 510(K)Number: K143085 K121308
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Accolade and Restoration hip product; Catalog Number: 6021-0030, 6276-1-127, 6276-5-216, 6020-2530, 6020-4535, 6021-0740, 6021-0230, and 6021-4535
• Code Information: Lot: 55624702, 55709001, 55709002, 55709003, 55959003, 55967305, 56011203, 56011205, 56011301, 56019501, and 56109304
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Michael Van Ryn; 201-831-5838
• Manufacturer Reason for Recall: Inner and outer sterile barriers not fully sealed.
• FDA Determined Cause: Process control
• Action: Recall notices were sent to customers with a request to return all affected product.
• Quantity in Commerce: 255
• Distribution: Distributed in ten (10) states: AR, DE, FL, IL, IN, MI, NJ, OH, TN, and TX; and Canada, Sweden, United Kingdom, France, Spain, Italy, Japan, Romania, Colombia, Netherlands, and Australia.
• 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 = LPH and Original Applicant = HOWMEDICA OSTEONICS CORP; 510(K)s with Product Code = LPH and Original Applicant = STRYKER ORTHOPAEDICS