PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes

FDA device recall Z-0842-2016 · posted 2016-02-22 · Terminated

Recall details

Recalling firm

Zimmer Biomet, Inc.

Reason for recall

LDPE bag containing the implant adheres to the highly polished implant surface.

Action taken

Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative. For questions regarding this recall call 800-447-5633.

Root cause

Process control

Status

Terminated

Product code

NJL

Quantity affected

4567

Distribution

Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC

Date initiated

2016-01-11

Date posted

2016-02-22

Date terminated

2017-05-23

Location

Warsaw, IN