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U.S. Department of Health and Human Services

Class 2 Device Recall NaturalKnee II Durasul AllPoly Patella, Size 0, 7mm

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 Class 2 Recall
NaturalKnee II Durasul AllPoly Patella, Size 0, 7mm
see related information
Date Posted January 25, 2012
Recall Status1 Open
Recall Number Z-0848-2012
Recall Event ID 60858
Premarket Notification
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 0, 7mm 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 6301-07-100; all lots
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw, Indiana 46580-2746
Consumer Instructions Contact the recalling firm for information
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 2
DESIGN: 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.
Quantity in Commerce TBD
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = SULZER ORTHOPEDICS, INC.
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