Recall StatusTerminated
Date Initiated2014-07-10
Date Terminated2015-08-20
Product Quantity8638 distribution events
Reason for Recall
Zimmer received a trend of complaints indicating corrosion of product.
Firm Action
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.
Distribution Pattern
Worldwide Distribution - US Distribution and the countries of : Argentina, Australia, Brazil, France, Germany, India, Japan, Spain, Switzerland, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.