Recalls / —

—#120702

Product

Gender Solutions" Patello-Femoral Component

FDA product code

KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K070695

Affected lot / code info

Part Number Range:00-5926-011/015-01/02

Why it was recalled

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Root cause (FDA determination)

Package design/selection

Action the firm took

August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.

Recalling firm

Firm

Zimmer, Inc.

Address

345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.

Timeline

Recall initiated

2013-08-30

Posted by FDA

2013-10-25

Terminated

2014-09-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #120702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.