Class 2 Device Recall Altrx" Altralinked" Polyethylene liners

• Date Initiated by Firm: July 24, 2012
• Date Posted: August 17, 2012
• Recall Status: Terminated on April 30, 2013
• Recall Number: Z-2220-2012
• Recall Event ID: 62649
• 510(K)Number: K102423
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one of the implants used during total hip arthroplasty to replace the damaged hip joint to help increase patient mobility and to reduce pain. Packaging: Product is placed into a PETG tray, sealed with a Tyvek lid. This is placed into a second PETG tray and sealed with a Tyvek lid. This package is placed into a paperboard carton, labeled, and shrink-wrapped. Intended Use: An acetabular liner is used in combination with other implants for total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
• Code Information: Catalog number: 1221-36-054 and Lot Number: 231859
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: 574-267-8143
• Manufacturer Reason for Recall: In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner.
• FDA Determined Cause: Employee error
• Action: Depuy sent an URGENT MEDICAL DEVICE RECALL notification dated July 24, 2012, to all affected consignees. The recall is extended to the Depuy Distributor level and hospital level. All DePuy Distributors were notified via email. The sales representatives notify the hospital either by mail or in person with a written communication. Distributors and customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN. The sales representatives are expected to aid customer in returning of recalled products. Distributors and sales representatives are to return the recalled products through the normal DePuy Returns process, to attention of Returns and marking H12-16 on the outside of the box. Reconciliation forms should be returned to the DePuy Sales Representative or faxed to 574-372-7567. For clinical questions from Surgeons contact DePuy's Scientific Information Office at 1-888-554-2482. For questions regarding recall information call 574-372-7333.
• Quantity in Commerce: 20 liners
• Distribution: Worldwide Distribution - USA including PA and the country of Canada
• 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