Z-0848-2012

Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul Patella product is a...

Name: Z-0848-2012 Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul Patella product is a...
Creator: Zimmer Inc.
Published: 2011-12-21
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-12-21 / Terminated / root cause: design

FDA source

Zimmer Inc. began a recall of 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... on 2011-12-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0848-2012
Status: Terminated
Initiated: 2011-12-21
Posted: 2012-01-25
Terminated: 2015-08-21
Recalling firm: Zimmer GmbH
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.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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
Root cause tag: design
FDA root 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.
Quantity in commerce: TBD
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Belgium, Germany, France, Austria, Sweden, Switzerland, South Africa, and the UK
Product codes and lots: 6301-07-100; all lots

Product code JWH

K002335Class IINatural-Knee II System-Durasul Tibial Insert and Durasul All-Poly PatellaSulzer Orthopedics, Inc. / cleared 2000-10-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)