Natural-Knee System Patella Bushings. Orthopedic surgical instrument. Part Number 6290-00-690. Per the Natural-Knee II P

FDA device recall Z-2582-2014 · posted 2014-09-04 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer received a trend of complaints indicating corrosion of product.

Action taken

Zimmer issued an Urgent Medical Device Recall-Lot Specific notification via e-mail/letter dated July 19, 2014, to all affected customers. The notification identified the product the problem and the action needed to be taken by the customer. All distributors were notified via electronic mail. Hospital risk managers and surgeons, as well as distributors with affected inventory were notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory as well as identifying hospitals and surgeons who have previously used the affected product. Distributors are to return on-hand affected products to Zimmer, and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative. If you have questions or concerns regarding this recall please call the customer call center at 1-877-946-2761.

Root cause

Device Design

Status

Terminated

Product code

JWH

Quantity affected

8638 distribution events

Distribution

Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.

Date initiated

2014-07-10

Date posted

2014-09-04

Date terminated

2015-08-20

Location

Warsaw, IN

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