NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness Non sterile, Rx Only Devices are used

FDA device recall Z-0460-2014 · posted 2013-12-06 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.

Action taken

Zimmer sent an Urgent Medical Device Recall Notice dated November 19, 2013, to all affected customers. The Notice outlined the products recalled; the reason for the recall, possible adverse events related to the recall and directed consignees to locate, quarantine and count all affected product recording the information on the Inventory Return Form acknowledging that recall directions were followed. Further questions should be directed to 1-877-946-2761. Affected product will be removed by a Zimmer Sales representative, Question should be directed to 1-877-946-2761 8a.m - 5 p.m. EST. For questions regarding this recall call 800-613-6131.

Root cause

Labeling design

Status

Terminated

Product code

FZX

Quantity affected

641 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, Sout

Date initiated

2013-11-19

Date posted

2013-12-06

Date terminated

2015-05-06

Location

Warsaw, IN