Class 2 Device Recall Restoration Modular Cone Bodies

• Date Initiated by Firm: April 02, 2009
• Date Posted: May 21, 2009
• Recall Status: Terminated on August 27, 2012
• Recall Number: Z-1642-2009
• Recall Event ID: 51868
• 510(K)Number: K013106 K022549 K040734
• Product Classification: Femoral Hip Prosthesis - Product Code LZO
• Product: Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Howmedica Osteonics Corp, Stryker Ireland, Carrighwohill Sterile. Intended Use: For primary or revision total hip arthroplasty and severe proximal bone loss. Stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. Conditions for which product may be appropriate for use: rheumatoid arthritis, correction of deformity, non-inflammatory degenerative joint disease, revision surgery, treatment of non-union, fracture of proximal femur with head involvement.
• Code Information: Lot # 211080002; Lot # 22109602; Lot # 21883201; Lot # 21910302 and 21883401.
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430
• For Additional Information Contact: Colleen O'Meara; 201-831-5970
• Manufacturer Reason for Recall: Packaging burst test values for the Restoration Modular Cone Body family were found to be incorrectly transferred from the finalized validation to the work specification. Testing showed that burst test results for recalled products fell below the validated parameters.
• FDA Determined Cause: Process control
• Action: Urgent Product Recall letters were sent via Federal Express on April 2, 2009 to Stryker branches, Chief of Orthopaedics, Hospital Rick Management and Surgeons. The letter stated the issue, the potential hazards, and the risk mitigation. Customers were asked to examine their inventory and hospital locations to identify the affected products; retrieve all effected products and return it to their branch or agency warehouse for reconciliation; reconcile all products on the attached Product Accountability Form and fax a copy to the number listed; return the affected product via the Inter-Org Transfer and ship it to the attention of the individual listed; attach the fluorescent orange PRODUCT REMEDIATION sticker to their return, indicating the Product Remediation #, and mark the box with the words "PRODUCT RECALL". Questions should be directed to Colleen O'Meara at 201-831-5970.
• Quantity in Commerce: 17 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 = LZO