Class 2 Device Recall NaturalKnee II Durasul AllPoly Patella, Size 3, 10mm

• Date Initiated by Firm: December 21, 2011
• Date Posted: January 25, 2012
• Recall Status: Terminated on August 21, 2015
• Recall Number: Z-0855-2012
• Recall Event ID: 60858
• 510(K)Number: K002335
• Product Classification: Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
• Product: Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed components: the femoral, tibial, articular surface, and patellar prosthesis. The all-polyethylene patella is made from Durasul Highly Crosslinked Ultra High Molecular Weight Polyethylene. The N-K II Durasul polyethylene patella components are indicated for patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.
• Code Information: 6301-10-107; all lots
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-372-4807
• Manufacturer Reason for Recall: The firm has 16 reports of patella peg shear out of 109,386 distributed units (0.0137%). The failures have been reported where the pegs on the back side of the patella have sheared at the peg/patella interface. Analysis shows that the highly cross-linked polyethylene, Durasul, patella was shown to have a lower fracture fatigue strength than the Sulene counterpart and that the cement technique used
• FDA Determined Cause: Component design/selection
• Action: Zimmer sent an Urgent Device Recall letter dated December 20, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distribution of the affected product and return all lots in inventory. Customers should provide a list of all hospitals and surgeons that have used the affected product by completing the User Facility and Health Care Professional Form and fax a copy to (574) 372-4265. If customers distributed the product further they should provide a copy of the recall letter to those customers. For questions regarding this recall call 1-877-946-2761.
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Belgium, Germany, France, Austria, Sweden, Switzerland, South Africa, and the UK
• 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 = JWH