Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-cons

FDA device recall Z-0855-2012 · posted 2012-01-25 · Terminated

Recall details

Recalling firm

Zimmer Inc.

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

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

JWH

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Belgium, Germany, France, Austria, Sweden, Switzerland, South Africa, and the UK

Date initiated

2011-12-21

Date posted

2012-01-25

Date terminated

2015-08-21

Location

Warsaw, IN

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